DEVICE: Western/Scott Fetzer (B929C4NI240MP4MP40)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

Western/Scott Fetzer
C4NI-240MP4MP4
In Commercial Distribution
C4NI-240MP4MP4
Western Enterprises
B929C4NI240MP4MP40
HIBCC

1
148634731 *Terms of Use
PKGD: C4-NIT-240-MP4-MP4
CLOSE

Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40543 Nitrogen quick-connect coupling, male
A male connecting device used to connect to a medical gas pipeline system or other gas source allowing a user to rapidly connect and disconnect nitrogen (N2) dependent devices to the nitrogen supply. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection. It is used to connect into a nitrogen terminal unit or female connector. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BYX Tubing, Pressure And Accessories
CLOSE

FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6e5423d3-8a2c-40db-bb48-9e3e22a5cf71
August 14, 2024
2
June 17, 2022
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
1-800-783-7890
SALES@WESTERNENTERPRISES.COM
CLOSE