Enteral

Basic Information

• Brand Name: Enteral
• Primary DI: 05060460843727
• Version / Model: DBISO-50
• Catalog Number: DBISO-50
• 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: 2
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: d6168598-6e29-48c6-8f4d-fb9fea664aca

Device Description

Enteral, Drainage Bag, EVA, Single Use 50ml

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: 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	05060460843741	GS1	Case	6	In Commercial Distribution
Package	05060460843734	GS1	Box	20	In Commercial Distribution
Primary	05060460843727	GS1