FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10197344170203
·
Model: MPHD10CARD
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10197344170203
- Version / Model
- MPHD10CARD
- Catalog Number
- MPHD10CARD
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-29
- Public Version
- 1
- Public Version Date
- 2026-02-06
- Public Version Status
- New
- Public Device Record Key
- 1357f49c-d212-444b-81df-0e3bdc838093
Device Description
TEST,DRUG,10 PANEL DIP CARD, 25/BX,CLIA
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFT | TEST, AMPHETAMINE, OVER THE COUNTER | Clinical Toxicology | 862.3100 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | 20197344170200 | GS1 | BX | 25 | In Commercial Distribution | |
| Primary | 10197344170203 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202567 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Freeze; Keep Dry; Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius