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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 9-45
Standard
ASTM F2528-06 (Reapproved 2014)
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Scope/Abstract
These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of natural orifice (nasal, oral, transluminal) and or a surgically created stoma. The product is manufactured in various s and materials such as silicone, urethane, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Rationale for these test methods can be found in Appendix X1.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5980 Tube, Nasogastric Class 2 BSS
§876.5980 Catheter, Retention Type Class 2 EZK
§876.5980 Bag, Hemostatic Class 2 FCB
§876.5980 Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 Tube, Double Lumen For Intestinal Decompression And/Or Intubation Class 2 FEG
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Catheter, Retention, Barium Enema With Bag Class 2 FGD
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Levine Class 2 FRQ
§876.5980 Catheter, Rectal Class 2 GBT
§876.5980 Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Class 2 KDH
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT
§876.5980 Intestinal Splinting Tubes Class 2 LCG
§876.5980 Rectal Insert Class 2 PBP
§876.5980 Esophageal Dilator Balloon With Or Without Electrode Sensors Class 2 PID
§876.5980 Esophageal Dilator With Balloon And Electrode Sensors Class 2 PIE
§876.5980 Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Enteral Specific Transition Connectors Class 2 PIO
§876.5980 Gastrointestional Tube Holder Class 2 PLI
§876.5980 Enteral Syringes With Enteral Specific Connectors Class 2 PNR
§876.5980 Enteral Administration Kit (Adult & Pediatric) Class 2 PRM
§876.5980 Balloon Gastrostomy Tube Kit Class 2 PRP
§876.5980 Feeding Tube Kit Class 2 PRR
§876.5980 Gastric Colonic Catheter Irrigation Kit Class 2 PRS
§876.5980 Gastric Irrigation And Aspiration Kit Class 2 PRT
§876.5980 Gastrointestinal Tube Kit Class 2 PRW
§876.5980 Gastrostomy Guide Wire Placement Kit Class 2 PRX
§876.5980 Gastrostomy Jejunostomy Feeding Tube Kit Class 2 PRY
§876.5980 Gastrostomy Tube Kit Class 2 PRZ
§876.5980 Laparoscopic Jejunostomy Kit Class 2 PSA
§876.5980 Nasogastric Feed Tube Kit Class 2 PSB
§876.5980 Nasogastric-Gastrojejunal Kit Class 2 PSC
§876.5980 Laparoscopic Gastrostomy Kit Class 2 PSD
§876.5980 Needle Catheter Jejunostomy Kit Class 2 PSE
§876.5980 Non-Balloon Replacement Gastrostomy System Class 2 PSF
§876.5980 Percutaneous Endoscopic Gastrostomy Kit Class 2 PSG
§876.5980 Percutaneous Replacement Gastrostomy Tube Kit Class 2 PSH
§876.5980 Replacement Gastrostomy Feeding Catheter Tray Class 2 PSK
§876.5980 Pediatric Esophageal Atresia Anastomosis Device Class 3 PTK
§876.5980 Set, Oral Administration Class 2 LEY
§876.5980 Perineal Irrigation Kit Class 2 PSI
§876.5980 Tray, Irrigation, Sterile Class 2 EYN
§876.5980 Balloon, Liver Tamponade Class 2 NGU
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Mark Antonino
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  240-402-9980
  Mark.Antonino@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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