FDA UDI
In Commercial Distribution
🇺🇸 United States
TruSignal SpO2
DI: 00840682147293
·
Model: TS-RWM-24
·
GE Healthcare Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TruSignal SpO2
- Primary DI
- 00840682147293
- Version / Model
- TS-RWM-24
- Catalog Number
- TS-RWM-24
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-03
- Public Version
- 3
- Public Version Date
- 2025-06-16
- Public Version Status
- Update
- Public Device Record Key
- 0199b303-3fe7-4c8d-8a1d-c4c93b4754ac
Device Description
Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs
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
- 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 |
|---|---|---|---|---|
| DPZ | Oximeter, ear | Cardiovascular | 870.2710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35709 | Electrode/transducer strap, reusable | A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682147293 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093881 | 000 |