FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ChekMate™ Strips
DI: 00381930860019
·
Model: 860
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- ChekMate™ Strips
- Primary DI
- 00381930860019
- Version / Model
- 860
- Catalog Number
- 860
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-07-15
- Public Version
- 5
- Public Version Date
- 2022-04-13
- Public Version Status
- Update
- Public Device Record Key
- a6e7d522-4721-4187-96e5-a5c878e0ba94
- Distribution End Date
- 2020-01-01
Device Description
ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | Clinical Chemistry | 862.1175 | 1 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| LBR | LDL & VLDL PRECIPITATION, HDL | Clinical Chemistry | 862.1475 | 1 |
| JGY | COLORIMETRIC METHOD, TRIGLYCERIDES | Clinical Chemistry | 862.1705 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52851 | Glucose/ketone/lipid profile IVD, calibrator | A material which is used to establish known points of reference for a number of assays intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00381930860019 | GS1 | ||||
| Unit of Use | 10381930860016 | GS1 |
Customer Contacts
- Phone
- +1(888)877-5610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151530 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The strips should always be stored in the original container when not in use to protect from light and from accidental scratching.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose strips to high humidity, extreme heat, cold, dust or dirt.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 80 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 27 Degrees Celsius