Identity
- Trade Name
- SAK1560T FDA UDI
- Generic Name
- Pressure transducer dome, single-use FDA UDI
- Device Name
- 60 drops, 60" tube length AdSet packs together with a Critiflo Dome connected with a Dampling device and a 48" & 12" pressure Tubing and 2x 3-Way White Stopcocks. It includes a separately packed 2x Male protective caps. FDA UDI
- Model / Reference
- 682176 FDA UDI
- Description
- 60 drops, 60" tube length AdSet packs together with a Critiflo Dome connected with a Dampling device and a 48" & 12" pressure Tubing and 2x 3-Way White Stopcocks. It includes a separately packed 2x Male protective caps. FDA UDI
Identifiers
- Catalog Number
- 682176 FDA UDI
- Primary DI / UDI-DI
- 00886333621767 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Pressure transducer dome, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 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
Sak1560t 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 aaca8ae7-c3fc-4688-8bd4-9d4621cf942b 36 fields · synced Jun 1, 2026