Identity
- Trade Name
- UNIV HOSP CLEVELAND SWAN MON ADULT SET FDA UDI
- Generic Name
- Invasive blood pressure monitoring tubing set FDA UDI
- Device Name
- a single 3cc transducer connected to a 20 drops, 60" tube Adset. Patient line is connected to a 6" Prressure tube via a 2-way red stopcock with its side port connected to 3-way white stopcock and a 6" pressure tube. FDA UDI
- Model / Reference
- 687365 FDA UDI
- Description
- a single 3cc transducer connected to a 20 drops, 60" tube Adset. Patient line is connected to a 6" Prressure tube via a 2-way red stopcock with its side port connected to 3-way white stopcock and a 6" pressure tube. FDA UDI
Identifiers
- Catalog Number
- 687365 FDA UDI
- Primary DI / UDI-DI
- 00886333673650 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Invasive blood pressure monitoring tubing set 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: Invasive blood pressure monitoring tubing set
Univ Hosp Cleveland Swan Mon Adult 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 e0152b7d-0af9-4a31-a0e5-973df946cdd1 36 fields · synced May 30, 2026