AccessGUDID - DEVICE: BOEHRINGER® NCG Round Adapter (10816286020352)

GUDID

Device Identifier (DI) Information

Brand Name: BOEHRINGER® NCG Round Adapter
Version or Model: 1494
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1494
Company Name: BOEHRINGER LABORATORIES, LLC

Primary DI Number: 10816286020352
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 079991657 *Terms of Use

Device Description: NCG Round Adapter

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:	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?
45808	Vacuum quick-connect coupling, male	A male connecting device intended to be used to connect to a medical gas/vacuum pipeline system or other vacuum connection allowing a user to rapidly connect and disconnect vacuum dependent devices to the vacuum source. 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 vacuum 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

FDA Product Code

[?]

Product Code	Product Code Name
KDP	Regulator, Vacuum

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: 8df25773-1b70-4a28-a062-46912322837e
Public Version Date: August 08, 2023
Public Version Number: 3
DI Record Publish Date: August 01, 2016