Recognized Consensus Standards

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

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.