PharmChek (R) Drugs of Abuse Sweat Patch

GUDID 00860001701005

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.

PHARMCHEM, INC.

Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD
Primary Device ID00860001701005
NIH Device Record Key581a6ae6-5c1b-4749-8430-0edfdf668e69
Commercial Distribution StatusIn Commercial Distribution
Brand NamePharmChek (R) Drugs of Abuse Sweat Patch
Version Model NumberSingle Patch
Company DUNS198063752
Company NamePHARMCHEM, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com
Phone855-458-4100
Emailinfo@pharmchem.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001701005 [Primary]
GS100860001701029 [Package]
Package: Box of 50 [50 Units]
In Commercial Distribution
GS100860001701036 [Package]
Package: Box of 10 [10 Units]
In Commercial Distribution
GS110860001701026 [Package]
Contains: 00860001701029
Package: Shipper Case [32 Units]
In Commercial Distribution
GS110860001701033 [Package]
Contains: 00860001701036
Package: Shipper CS - 10ct [112 Units]
In Commercial Distribution
GS120860001701023 [Package]
Contains: 10860001701026
Package: Shipping Pallet [24 Units]
In Commercial Distribution

FDA Product Code

FMHContainer, Specimen, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-22
Device Publish Date2019-06-30

Devices Manufactured by PHARMCHEM, INC.

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10860001701064 - PharmChem, Inc. Transparent Overlay Film with Cutout2019-09-09 PharmChem, Inc. Transparent Overlay Film (4" x 5") with Cutout (1" x 1.65").
00860001701005 - PharmChek (R) Drugs of Abuse Sweat Patch2019-08-22PharmChek® 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.
00860001701005 - PharmChek (R) Drugs of Abuse Sweat Patch2019-08-22 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
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