Adapter , Box10
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Adapter, Box10 EUDAMEDAdapter , Box10 FDA UDI
- Generic Name
- Non-ISO80369-standardized small-bore linear connector, reusable FDA UDI
- Model / Reference
- MP00945 EUDAMEDFDA UDI1080036K19K010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675267706 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867511080036K19K010KE EUDAMED
- Unit of Use DI
- 04048675448419 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Non-ISO80369-standardized small-bore linear connector, reusable
Adapter , Box10 by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Non-ISO80369-standardized small-bore linear connector, reusable.
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- NBP extension hose, adult 3, 7m — Drägerwerk AG & Co. KGaA · Class II
Cleared under the same submission
K092999 also covers:
- 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
- NBP Cuff S, 17-25/29cm, Box10 — Drägerwerk AG & Co. KGaA
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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI ebe1e73f-6916-474a-bf0c-5b5bb805a579 33 fields · synced Jul 26, 2026
- EUDAMED 3609d708-14ca-492b-bb54-eed088e4d42c 61 fields · synced Jul 26, 2026