FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BRAUN
DI: 00328785014051
·
Model: PRT2100USV1
·
KAZ USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BRAUN
- Primary DI
- 00328785014051
- Version / Model
- PRT2100USV1
- Company Name
- KAZ USA, INC.
- Labeler DUNS
- 122612547
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-23
- Public Version
- 1
- Public Version Date
- 2025-06-02
- Public Version Status
- New
- Public Device Record Key
- 8799b0f8-b687-4d3c-aea8-5fa16f52d5bb
- Distribution End Date
- 2025-05-23
Device Description
BRAUN DIGITAL STICK WITH FEVER GUIDANCE
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 00328785014044 | GS1 | ||||
| Primary | 00328785014051 | GS1 | ||||
| Package | 10328785014058 | GS1 | CASE | 24 | Not in Commercial Distribution | 2025-05-22 |