Identity
- Trade Name
- PROVIDENCE HOSPITAL - ONE LINE SET FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 24" Small Bore tube , a 1-way stopcock and another 6" small bore tube connect to the Septum Device. The other end of the device connects to a 3-way Red and a 3-way White stopcocks , a 6" Pressure Tubing which cis connected to a 5cc Restricted Syringe with touchguard stops at 3cc. FDA UDI
- Model / Reference
- 688075 FDA UDI
- Description
- 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 24" Small Bore tube , a 1-way stopcock and another 6" small bore tube connect to the Septum Device. The other end of the device connects to a 3-way Red and a 3-way White stopcocks , a 6" Pressure Tubing which cis connected to a 5cc Restricted Syringe with touchguard stops at 3cc. FDA UDI
Identifiers
- Catalog Number
- 688075 FDA UDI
- Primary DI / UDI-DI
- 00886333680757 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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: Arterial blood sampling kit
Providence Hospital - One Line Set 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 b1434ee9-9bbd-498b-972a-cdecbeec9fd4 36 fields · synced Jun 1, 2026