Identity
- Trade Name
- CRITIFLO(TM) TAK1760M FDA UDI
- Generic Name
- Pressure transducer dome, single-use FDA UDI
- Device Name
- A separate 60 drops,60" tube Adset and a Critiflo flushing device connected to a 3-Way White OFF stopcock, Pressure tubing of length 48", 3-Way White OFF stopcock and 12" Pressure tubing. It also includes a separately packed 2x male protective caps. FDA UDI
- Model / Reference
- 682128 FDA UDI
- Description
- A separate 60 drops,60" tube Adset and a Critiflo flushing device connected to a 3-Way White OFF stopcock, Pressure tubing of length 48", 3-Way White OFF stopcock and 12" Pressure tubing. It also includes a separately packed 2x male protective caps. FDA UDI
Identifiers
- Catalog Number
- 682128 FDA UDI
- Primary DI / UDI-DI
- 00886333621286 FDA UDI
- FDA Product Code
- DXO FDA UDI
- GMDN Term
- Pressure transducer dome, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2870 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
Yes
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
No
FDA UDI
Category: Pressure transducer dome, single-use
Critiflo(tm) Tak1760m by Argon Critical Care Systems Singapore Pte. Ltd. — 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
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 64d20120-9d02-4ea7-8f3d-71c021f3c284 36 fields · synced Jun 1, 2026