AccessGUDID - DEVICE: Western/Scott Fetzer (B929C4NI144FNNSHF0)

GUDID

Device Identifier (DI) Information

Brand Name: Western/Scott Fetzer
Version or Model: C4NI-144FNNSHF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C4NI-144FNNSHF
Company Name: Western Enterprises

Primary DI Number: B929C4NI144FNNSHF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148634731 *Terms of Use

Device Description: PKGD: C4-NIT-144-FNN-SHF

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
37934	Nitrogen quick-connect coupling, female	A female connecting device used to accept a male nitrogen (N2) connector to connect two devices together to provide a continuous passageway for the delivery of nitrogen. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection and allow a user to rapidly connect and disconnect nitrogen dependent devices. It can be attached, e.g., to a nitrogen regulator or a nitrogen extension tubing. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. This is not a nitrogen terminal unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 268ce831-a89d-4911-bea7-448d9da86838
Public Version Date: August 14, 2024
Public Version Number: 2
DI Record Publish Date: June 17, 2022