SpO2 Draeger Infant Band, 24 pcs.
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SPO2 DRÄGER SÄUGL. BAND, 24STK EUDAMEDSpO2 Draeger Infant Band, 24 pcs. FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Model / Reference
- MS16447 EUDAMEDFDA UDI005333 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098005333 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098005333 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Pulse oximeter probe, single-use
SpO2 Draeger Infant Band, 24 pcs. by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI 9becd7dd-a949-4095-93d2-b92818693c8c 33 fields · synced Jun 19, 2026
- EUDAMED f4cc7980-25a9-4a5d-826c-6a0838a9b0ac 61 fields · synced Jun 19, 2026