NIBP Neo #3 Cuff 5.8 - 10.9 cm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- NIBP Neo #3 Mansch 5,8-10,9cm EUDAMEDNIBP Neo #3 Cuff 5.8 - 10.9 cm FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Model / Reference
- 2870207 EUDAMEDFDA UDI1070246K19Z020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098060608 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867521070246K19Z020RM EUDAMED
- Unit of Use DI
- 04049098060592 EUDAMED
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Blood pressure cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Blood pressure cuff, single-use
NIBP Neo #3 Cuff 5.8 - 10.9 cm by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 7647ce3a-4843-4580-99e4-430d363e001a 33 fields · synced Jul 10, 2026
- EUDAMED b48addf2-d133-4f3e-a5ce-3bc2ccdbd5dd 61 fields · synced Jul 10, 2026