AccessGUDID - DEVICE: Mission Saliva Test Strips (00682607200054)

GUDID

Device Identifier (DI) Information

Brand Name: Mission Saliva Test Strips
Version or Model: C031-021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Acon Laboratories, Inc.

Primary DI Number: 00682607200054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 781100966 *Terms of Use

Device Description: Mission Saliva Alcohol Test Strips

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
62049	Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIC	ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093879	000

Device Exempt from Premarket Submission: No 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 36 and 81 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96e37f4c-a20f-4aa8-8822-24304df923e0
Public Version Date: June 20, 2025
Public Version Number: 5
DI Record Publish Date: September 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20682607200058	80	00682607200054		In Commercial Distribution	Carton

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00682607000272 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(800)838-9502 ext: 1
Email: support@aconlabs.com

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