FDA UDI
In Commercial Distribution
🇺🇸 United States
American Red Cross
DI: 84617503102012
·
Model: PC868
·
CREATIVE CONCEPTS MANUFACTURING LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- American Red Cross
- Primary DI
- 84617503102012
- Version / Model
- PC868
- Catalog Number
- AR3102
- Company Name
- CREATIVE CONCEPTS MANUFACTURING LIMITED
- Labeler DUNS
- 680004711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-19
- Public Version
- 1
- Public Version Date
- 2021-11-29
- Public Version Status
- New
- Public Device Record Key
- 2171c7cc-5b8b-4ea8-ae3d-44b8f20f1114
Device Description
Intended Use This infrared thermometer is intended to measure the body temperature of infants and adults without contact. It can also be used to measure surface temperatures of objects such as baby bottles, bath water, pool water, vents and more. Perfect for home, office or clinical use.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 84617503102012 | GS1 | ||||
| Package | 84617503102128 | GS1 | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-201-656-2077
- [email protected]