FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDISANA
DI: 04015588996528
·
Model: TM A75
·
Medisana GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDISANA
- Primary DI
- 04015588996528
- Version / Model
- TM A75
- Catalog Number
- 99652
- Company Name
- Medisana GmbH
- Labeler DUNS
- 319241873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-18
- Public Version
- 2
- Public Version Date
- 2021-07-15
- Public Version Status
- Update
- Public Device Record Key
- c643b9db-a226-4824-a66b-ccc718aae273
Device Description
a hand-held, battery-powered, electronic instrument designed to measure :1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of the site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip.This device is intended for use in the home or healthcare facility. It is a reusable device
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 63711 | Infrared patient thermometer, ear/skin | A hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04015588987571 | GS1 | cardboard | 10 | In Commercial Distribution | |
| Primary | 04015588996528 | GS1 |
Customer Contacts
- Phone
- 2488633175
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102554 | 000 |