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Adapter NBP
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MP00957Model 1080036K19K010
Identity
- Trade Name
- Adapter NBP EUDAMEDFDA UDI
- Generic Name
- Non-ISO80369-standardized small-bore linear connector, reusable FDA UDI
- Model / Reference
- MP00957 EUDAMEDFDA UDI1080036K19K010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675252009 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867511080036K19K010KE EUDAMED
- 510(k) Number
- K092999 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Non-ISO80369-standardized small-bore linear connector, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Adapter NBP by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K092999 also covers:
- Adapter , Box10 — Drägerwerk AG & Co. KGaA
- NBP Cuff L+, 31-40/55cm — Drägerwerk AG & Co. KGaA
- NBP Cuff L+, 31-40/55cm, Box10 — Drägerwerk AG & Co. KGaA
- NBP Cuff L, 31-40cm — Drägerwerk AG & Co. KGaA
- NBP Cuff L, 31-40cm, Box10 — Drägerwerk AG & Co. KGaA
- NBP Cuff M++, 23-33/53cm — Drägerwerk AG & Co. KGaA
- NBP Cuff M++, 23-33/53cm, Box10 — Drägerwerk AG & Co. KGaA
- NBP Cuff M+, 23-33/43cm — Drägerwerk AG & Co. KGaA
- NBP Cuff M+, 23-33/43cm, Box10 — Drägerwerk AG & Co. KGaA
- NBP Cuff M, 23-33cm — Drägerwerk AG & Co. KGaA
- NBP Cuff M, 23-33cm, Box10 — Drägerwerk AG & Co. KGaA
- NBP Cuff S, 17-25/29cm — Drägerwerk AG & Co. KGaA
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 9e4f9c65-b3a8-4898-a0d9-02c953de300e 34 fields · synced Oct 7, 2026
- EUDAMED 70f465dd-dcb4-4614-a6e6-e05ccacf6c8b 61 fields · synced Jul 9, 2026