Enteral

Basic Information

• Brand Name: Enteral
• Primary DI: 05060590880401
• Version / Model: ENT-PHX
• Catalog Number: ENT-PHX
• Company Name: GBUK ENTERAL LIMITED
• Labeler DUNS: 216643186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 1
• Public Version Date: 2022-11-09
• Public Version Status: New
• Public Device Record Key: 2dbc533f-375b-4d04-8366-5693d6abca0e

Device Description

Enteral, Indicator Strips, pH, Single Use 2 – 9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JLL	TUBELESS ANALYSIS, GASTRIC ACIDITY	Clinical Chemistry	862.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62048	Gastric pH strip	A paper strip impregnated with an indicator solution (e.g., universal indicator) intended to be used to measure the pH of gastric aspirate to verify the depth of placement of a nasogastric feeding tube. The strip changes colour when exposed to an acidic or basic solution. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060590880418	GS1	Case	50	In Commercial Distribution
Primary	05060590880401	GS1
Unit of Use	05060590880395	GS1