BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

VersaSafe

DI: 07613203009515 · Model: 9391-0200 · BD Switzerland Sàrl

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: VersaSafe
Primary DI: 07613203009515
Version / Model: 9391-0200
Catalog Number: 9391-0200
Company Name: BD Switzerland Sàrl
Labeler DUNS: 482631558
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-22
Public Version: 5
Public Version Date: 2024-08-15
Public Version Status: Update
Public Device Record Key: 0d1cfa2d-f53d-44a9-8f85-f58daea3cc5c

Device Description

VersaSafe Plastic Cannula

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: 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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42727	Positive-pressure intravenous line needleless valve-connector	A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point positive pressure from the device causes a small volume of fluid to be expelled from the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613203009515	GS1
Package	27613203033613	GS1	Case	45	In Commercial Distribution

Customer Contacts

Phone: +1(800)854-7128
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -40 – 125 Degrees Fahrenheit