AccessGUDID - DEVICE: ACETAMINOPHEN PLUS 1 (B80010095200060)

GUDID

Device Identifier (DI) Information

Brand Name: ACETAMINOPHEN PLUS 1
Version or Model: ACETA+ 1 S F BD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B80010095200060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: No description.

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?
55235	Multiple-therapy therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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: 3a328706-f08b-4152-ae5a-c848d635a6df
Public Version Date: August 10, 2022
Public Version Number: 1
DI Record Publish Date: August 02, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B80010095200061	4	B80010095200060	In Commercial Distribution	Box
B80010095200062	5	B80010095200060	In Commercial Distribution	Box
B80010095200063	10	B80010095200060	In Commercial Distribution	Box
B80010095200066	25	B80010095200060	In Commercial Distribution	Box
B80010095200067	50	B80010095200060	In Commercial Distribution	Box
B80010095200068	100	B80010095200060	In Commercial Distribution	Box