NA

Basic Information

• Brand Name: NA
• Primary DI: 00085412000084
• Version / Model: 2B8045
• Catalog Number: 2B8045
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2017-01-13
• Public Version: 9
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: 1e81bff3-79bf-4200-b593-a0e9f3d6216e
• Distribution End Date: 2022-12-30

Device Description

Small Hand Sealer Clips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62454	Medical tubing clip/clamp, permanent	A non-sterile, small, metallic or plastic, clip-like device designed to irreversibly (permanently) compress a piece of medical device tubing to occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It is intended to be compressed onto the tubing and retain its compressed form. It may be referred to as a clip or a clamp. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412000084	GS1
Unit of Use	70085412000083	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]