AccessGUDID - DEVICE: Injection Cap (00801741037191)

GUDID

Device Identifier (DI) Information

Brand Name: Injection Cap
Version or Model: 7740100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7740100
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741037191
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: INJECTION CAP

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. 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
No Device Sizes

Device Record Status

Public Device Record Key: 4175d253-fa64-4bd9-a4ed-3474375fd993
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: September 16, 2016