Identity
- Trade Name
- Spu Skin Temp Probe Ped 1.6m FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Model / Reference
- MP00997 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675250517 FDA UDI
- 510(k) Number
- K121999 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose patient temperature probe, single-use
Spu Skin Temp Probe Ped 1.6m by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose patient temperature probe, single-use.
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Cleared under the same submission
K121999 also covers:
- Spu GP Temp Probe Adult 1.6m — Drägerwerk AG & Co. KGaA
- Spu GP Temp Probe Adult 3.0m — Drägerwerk AG & Co. KGaA
- Spu GP Temp Probe Ped 1.6m — Drägerwerk AG & Co. KGaA
- Spu GP Temp Probe Ped 3.0m — Drägerwerk AG & Co. KGaA
- Spu Skin Temp Probe Adult 1.6m — Drägerwerk AG & Co. KGaA
- Spu Skin Temp Probe Adult 3.0m — Drägerwerk AG & Co. KGaA
- Spu Skin Temp Probe Ped 3.0m — Drägerwerk AG & Co. KGaA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 846570dd-550a-4222-a095-267310470a1e 34 fields · synced Jun 1, 2026