Identity
- Trade Name
- Edi Cath. 8Fr/100cm 1/pkg FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Model / Reference
- 6686405 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710002124 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Neonatal/adult intensive-care ventilator
Edi Cath. 8Fr/100cm 1/pkg by Maquet Critical Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Manufacturer
- Maquet Critical Care AB
Sources (1)
- FDA UDI 38bf210f-1c37-4066-be8e-1d74e521e411 32 fields · synced May 31, 2026