FDA UDI
In Commercial Distribution
🇺🇸 United States
QUALITY CHOICE
DI: 00635515956971
·
Model: 89-331
·
CHAIN DRUG MARKETING ASSOCIATION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- QUALITY CHOICE
- Primary DI
- 00635515956971
- Version / Model
- 89-331
- Catalog Number
- QC-95697
- Company Name
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Labeler DUNS
- 011920774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-15
- Public Version
- 4
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 637228a0-f7ba-43d3-92f1-24bf961f6aeb
Device Description
Quality Choice Temple Touch Mini Thermometer
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This 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 | 10635515956978 | GS1 | Master Carton | 36 | In Commercial Distribution | |
| Package | 30635515956972 | GS1 | Intermediate | 3 | In Commercial Distribution | |
| Primary | 00635515956971 | GS1 |
Customer Contacts
- Phone
- 866-326-1313
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032362 | 000 |