Enteral

Basic Information

• Brand Name: Enteral
• Primary DI: 05060590889374
• Version / Model: DBP-250HT
• Catalog Number: DBP-250HT
• Company Name: GBUK ENTERAL LIMITED
• Labeler DUNS: 216643186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-19
• Public Version: 1
• Public Version Date: 2022-10-27
• Public Version Status: New
• Public Device Record Key: 962fa9cf-7cb8-41fe-8421-af381f47a986

Device Description

Enteral ISOSAF Single Use Drainage Bag 250ml

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: Labeling does not contain MRI Safety Information
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFD	EVACUATOR, BLADDER, MANUALLY OPERATED	Gastroenterology, Urology	876.4370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62286	Gastric drainage/decompression bag	A plastic sac intended to be used to collect stomach contents during gastric drainage/decompression, via an enteral tube (not included), to drain/empty stomach contents (e.g., prior to surgery, as therapy for obstructed bowel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060590889398	GS1	Box	4	In Commercial Distribution
Package	05060590889381	GS1	Box	20	In Commercial Distribution
Primary	05060590889374	GS1