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Fmt
FDA UDIClass II (US FDA UDI)
by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
Identity
- Trade Name
- FMT FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, invasive FDA UDI
- Device Name
- Reusable IBP (Invasive Blood Pressure) Adaptor and Extension Cable FDA UDI
- Model / Reference
- IBP-04/028 FDA UDI
- Description
- Reusable IBP (Invasive Blood Pressure) Adaptor and Extension Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08698870369161 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Patient monitoring system module, blood pressure, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, blood pressure, invasive
Fmt by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, blood pressure, invasive.
- Iradimed — Iradimed Corporation · Class II
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- Infinity Mpod Quad Hemo — Draeger Medical Systems, Inc. · Class II
- Surveyor S12/S19 Patient Cable — MORTARA INSTRUMENT, INC. · Class II
- IBP upgrd pkg/no accssry — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- IBP module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- IBP upgrd pkg/with accssry — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Iradimed — Iradimed Corporation · Class II
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
Sources (1)
- FDA UDI 205e8a5f-6ff7-4358-96ed-5c3d63668c7d 35 fields · synced May 30, 2026