AccessGUDID - DEVICE: Broviac (00801741036385)

GUDID

Device Identifier (DI) Information

Brand Name: Broviac
Version or Model: 0601610
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0601610
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741036385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: 4.2F Broviac CV Catheters 0.7 mm Lumen (White Adapter) Repair Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65099	Central venous catheter repair kit	A collection of devices intended to repair an in situ central venous catheter by replacing the damaged external (proximal) portion of the catheter. It includes the replacement proximal section of the catheter and devices associated with the adhesion of this section to the catheter portion remaining in situ (e.g., adhesive material, needle, syringe, sleeve); a complete central venous catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJS	Catheter,intravascular,therapeutic,long-term greater than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 4.2 French

Device Record Status

Public Device Record Key: 43ea8d37-ec81-4f38-8535-aba7a812b85c
Public Version Date: August 28, 2024
Public Version Number: 4
DI Record Publish Date: July 27, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10801741036382	80	00801741036385		In Commercial Distribution	CA

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)545-0890
Email: medical.services@crbard.com

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