FDA UDI
In Commercial Distribution
🇺🇸 United States
Tempus LS-Manual
DI: 05060472441423
·
Model: 01-3012
·
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tempus LS-Manual
- Primary DI
- 05060472441423
- Version / Model
- 01-3012
- Company Name
- REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
- Labeler DUNS
- 896707940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-02
- Public Version
- 2
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 63076923-b342-49b3-87cc-a6c988a06276
Device Description
Tempus LS Mount
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | 870.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61434 | Portable active medical device mount | A device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060472441423 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200849 | 000 |