AccessGUDID - DEVICE: BENZODIAZEPINES -25% (B80003716500100)

GUDID

Device Identifier (DI) Information

Brand Name: BENZODIAZEPINES -25%
Version or Model: BENZO -25 PM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BENZO -25 PM
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B80003716500100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: BENZODIAZEPINES -25%

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):	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?
55527	Benzodiazepine group IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 78ff07f7-4197-485e-9929-b5fee45cc1e3
Public Version Date: April 18, 2023
Public Version Number: 2
DI Record Publish Date: August 15, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B80003716500101	4	B80003716500100	In Commercial Distribution	Box
B80003716500102	5	B80003716500100	In Commercial Distribution	Box
B80003716500103	10	B80003716500100	In Commercial Distribution	Box
B80003716500106	25	B80003716500100	In Commercial Distribution	Box
B80003716500107	50	B80003716500100	In Commercial Distribution	Box
B80003716500108	100	B80003716500100	In Commercial Distribution	Box