Enteral

Basic Information

• Brand Name: Enteral
• Primary DI: 05060590889435
• Version / Model: DBP-1000HT
• Catalog Number: DBP-1000HT
• 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: e6832d13-fbb9-4af5-9ef6-c2aa117721f2

Device Description

Enteral ISOSAF Single Use Drainage Bag 1000ml

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	05060590889442	GS1	Box	20	In Commercial Distribution
Primary	05060590889435	GS1
Package	05060590889459	GS1	Box	4	In Commercial Distribution