AccessGUDID - DEVICE: GHB 20 MG/L (B80001978000020)

GUDID

Device Identifier (DI) Information

Brand Name: GHB 20 MG/L
Version or Model: GHB 20 U IN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B80001978000020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: GHB 20 MG/L

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?
55644	Gamma-hydroxybutyrate (GHB) 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 gamma-hydroxybutyrate (GHB) 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b261edd9-b157-4dae-92af-1fc9a2f796fe
Public Version Date: August 22, 2022
Public Version Number: 1
DI Record Publish Date: August 12, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B80001978000021	4	B80001978000020	In Commercial Distribution	Box
B80001978000022	5	B80001978000020	In Commercial Distribution	Box
B80001978000023	10	B80001978000020	In Commercial Distribution	Box
B80001978000026	25	B80001978000020	In Commercial Distribution	Box
B80001978000027	50	B80001978000020	In Commercial Distribution	Box
B80001978000028	100	B80001978000020	In Commercial Distribution	Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888) 882-5522
Email: welovecontrol@utak.com

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