FDA UDI
In Commercial Distribution
🇺🇸 United States
Apex
DI: 00076855700327
·
Model: 70032
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Apex
- Primary DI
- 00076855700327
- Version / Model
- 70032
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 7
- Public Version Date
- 2023-09-04
- Public Version Status
- Update
- Public Device Record Key
- f3b97959-8deb-4bb0-9f90-067e7605b2d5
Device Description
TEMP*QWIK THERMOMETER CARDED
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | General Hospital | 880.2200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62296 | Liquid-crystal patient thermometer, reusable | A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40076855700325 | GS1 | CA | 24 | In Commercial Distribution | |
| Primary | 00076855700327 | GS1 | ||||
| Package | 30076855700328 | GS1 | CA | 144 | In Commercial Distribution | |
| Package | 50076855700322 | GS1 | CA | 144 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]