FDA UDI
In Commercial Distribution
🇺🇸 United States
PharmChek (R) Drugs of Abuse Sweat Patch
DI: 00860001701005
·
Model: Single Patch
·
PHARMCHEM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
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Basic Information
- Brand Name
- PharmChek (R) Drugs of Abuse Sweat Patch
- Primary DI
- 00860001701005
- Version / Model
- Single Patch
- Company Name
- PHARMCHEM, INC.
- Labeler DUNS
- 198063752
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-30
- Public Version
- 4
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- 581a6ae6-5c1b-4749-8430-0edfdf668e69
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001701005 | GS1 | ||||
| Package | 00860001701029 | GS1 | Box of 50 | 50 | In Commercial Distribution | |
| Package | 10860001701026 | GS1 | Shipper Case | 32 | In Commercial Distribution | |
| Package | 20860001701023 | GS1 | Shipping Pallet | 24 | In Commercial Distribution | |
| Package | 00860001701036 | GS1 | Box of 10 | 10 | In Commercial Distribution | |
| Package | 10860001701033 | GS1 | Shipper CS - 10ct | 112 | In Commercial Distribution |
Customer Contacts
- Phone
- 855-458-4100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 80 Degrees Fahrenheit