Identity
- Trade Name
- PROVIDENCE HOSPITAL - THREE LINE SET FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each end. 1 channel is connected with a septum with a 5cc syringe with touchguard stops at 3cc via a 48" & 6" Pressure Tubing & a 24" & 6" small bore tube from Patient. The other 2 lines connects directly to the 3cc transducer each, a 3-way stopcock and a 72" Pressure Tubing and a 3-way yellow stopcock for one line and a blue 3-way stopcock on the other line. . It includes a separately packed 10xmale & 10xfemale protective caps. FDA UDI
- Model / Reference
- 688062 FDA UDI
- Description
- A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each end. 1 channel is connected with a septum with a 5cc syringe with touchguard stops at 3cc via a 48" & 6" Pressure Tubing & a 24" & 6" small bore tube from Patient. The other 2 lines connects directly to the 3cc transducer each, a 3-way stopcock and a 72" Pressure Tubing and a 3-way yellow stopcock for one line and a blue 3-way stopcock on the other line. . It includes a separately packed 10xmale & 10xfemale protective caps. FDA UDI
Identifiers
- Catalog Number
- 688062 FDA UDI
- Primary DI / UDI-DI
- 00886333680627 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 - Three Line Set by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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 5544299e-bc4b-47f1-8fb6-c06a2330bdb1 36 fields · synced May 30, 2026