FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Redi-Temp®
DI: B2395010HB1
·
Model: 5010-H-B
·
TRADEMARK MEDICAL, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Redi-Temp®
- Primary DI
- B2395010HB1
- Version / Model
- 5010-H-B
- Catalog Number
- 5010-H-B
- Company Name
- TRADEMARK MEDICAL, L.L.C.
- Labeler DUNS
- 024113805
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2021-09-22
- Public Version Status
- Update
- Public Device Record Key
- db0aca50-4e5a-4d65-ab71-fb99f2bff302
- Distribution End Date
- 2020-03-31
Device Description
Liquid crystal temperature monitor strip (oval), individually wrapped, dispenser box
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 33618 | Liquid-crystal patient thermometer, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B2395010HB1 | HIBCC | ||||
| Unit of Use | B2395010HB0 | HIBCC |