PharmChek (R) Drugs of Abuse Sweat Patch

GUDID 00860001701005

Drug-testing specimen collection kit IVD

Primary Device ID	00860001701005
NIH Device Record Key	581a6ae6-5c1b-4749-8430-0edfdf668e69
Commercial Distribution Status	In Commercial Distribution
Brand Name	PharmChek (R) Drugs of Abuse Sweat Patch
Version Model Number	Single Patch
Company DUNS	198063752
Company Name	PHARMCHEM, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00860001701005 [Primary]
GS1	00860001701029 [Package] Package: Box of 50 [50 Units] In Commercial Distribution
GS1	00860001701036 [Package] Package: Box of 10 [10 Units] In Commercial Distribution
GS1	10860001701026 [Package] Contains: 00860001701029 Package: Shipper Case [32 Units] In Commercial Distribution
GS1	10860001701033 [Package] Contains: 00860001701036 Package: Shipper CS - 10ct [112 Units] In Commercial Distribution
GS1	20860001701023 [Package] Contains: 10860001701026 Package: Shipping Pallet [24 Units] In Commercial Distribution

FMH	Container, Specimen, Sterile

Steralize Prior To Use	false
Device Is Sterile	true

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00860001701005 - PharmChek (R) Drugs of Abuse Sweat Patch	2019-08-22PharmChek® 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 Patch	2019-08-22 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