Enteral

Basic Information

• Brand Name: Enteral
• Primary DI: 05060590881835
• Version / Model: MSISO-100P
• Catalog Number: MSISO-100P
• Company Name: GBUK ENTERAL LIMITED
• Labeler DUNS: 216643186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-28
• Public Version: 1
• Public Version Date: 2022-11-07
• Public Version Status: New
• Public Device Record Key: 2ccee48f-677d-4dfe-a568-013acba33575

Device Description

Enteral, Drawing Up Device, Medicine Straw, Single Use 8Fr x 100cm

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
KYX	DISPENSER, LIQUID MEDICATION	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64357	Medication transfer straw	A slender flexible tube with a blunt distal end intended to be attached to a syringe to aspirate pharmaceutical fluids from an open vial or ampule during the preparation of medications performed by healthcare professionals (e.g., pharmacists, physicians, nurses); it is not intended to puncture the seal of a vial/container. It is typically made of plastic and may include an integral filter intended to retain micro-particles to reduce the risk of particle contamination of the patient medication. It is not intended for skin injections or tissue manipulation and is not intended for enteral use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060590881859	GS1	Case	16	In Commercial Distribution
Package	05060590881842	GS1	Box	30	In Commercial Distribution
Primary	05060590881835	GS1