NA

Basic Information

• Brand Name: NA
• Primary DI: 00085412476865
• Version / Model: H93891
• Catalog Number: H93891
• Company Name: BAXTER CORPORATION ENGLEWOOD
• Labeler DUNS: 078383477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: b3878909-f265-4f75-adf5-45c750608b4c
• Distribution End Date: 2016-09-25

Device Description

Vial Adapter 20mm - Luer Lock

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHI	Set, i.V. Fluid transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60539	Vial/bottle adaptor, non-hermetic	A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412476860	GS1	CASE	50	Not in Commercial Distribution	2016-09-25
Primary	00085412476865	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K900585	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	20	Millimeter