AccessGUDID - DEVICE: INJECTION TUBE (04048223048900)

GUDID

Device Identifier (DI) Information

Brand Name: INJECTION TUBE
Version or Model: 001151-37W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001151-37W
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223048900
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223016029

Device Description: 001151-37W

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):	No
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
BSO	CATHETER, CONDUCTION, ANESTHETIC

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db2bbccc-ad89-4330-a58a-c2c069719622
Public Version Date: April 12, 2021
Public Version Number: 1
DI Record Publish Date: April 02, 2021