AccessGUDID - DEVICE: PharmChek (R) Drugs of Abuse Sweat Patch (00860001701005)

GUDID

Device Identifier (DI) Information

Brand Name: PharmChek (R) Drugs of Abuse Sweat Patch
Version or Model: Single Patch
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMCHEM, INC.

Primary DI Number: 00860001701005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198063752 *Terms of Use

Device Description: PharmChek® is a drug sweat patch worn on the skin surface for up to 10 days or longer that acts as a specimen container for the non-volatile and liquid components of sweat.

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):	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?
38868	Drug-testing specimen collection kit IVD	A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	Container, Specimen, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 581a6ae6-5c1b-4749-8430-0edfdf668e69
Public Version Date: July 22, 2021
Public Version Number: 4
DI Record Publish Date: June 30, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00860001701029	50	00860001701005	In Commercial Distribution	Box of 50
10860001701026	32	00860001701029	In Commercial Distribution	Shipper Case
20860001701023	24	10860001701026	In Commercial Distribution	Shipping Pallet
00860001701036	10	00860001701005	In Commercial Distribution	Box of 10
10860001701033	112	00860001701036	In Commercial Distribution	Shipper CS - 10ct