Identity
- Trade Name
- JEWISH HOSPITAL-OPEN HEART SET FDA UDI
- Generic Name
- Invasive blood pressure monitoring tubing set FDA UDI
- Device Name
- 4x 3cc transducers, each connects to a port of a 5-Gang Multiport. The middle port connects directly with a 20 drops, 60" Adset. The other 4 ports, each connects with a 6" Pressure Tubing with clamp. The 4 x 3cc transducers are individually connected to these tubings. The zeroing stopcock of transducer in port # 1 connects with a 12" Pressure tubing, with red tape for identification, It has a 60" &12" Pressure tubings connect to it via 2 separate 3-way red stopcocks. Port #2, transducer is connected with a 24" Pressure tubing identified with Yellow tape and a 3-Way yellow stopcock. Port # 4, with its transducer connects to a Blue taped 24" pressure tubing and a 3-Way blue stopcock. Port # 5 connects with a transducer. FDA UDI
- Model / Reference
- 686972 FDA UDI
- Description
- 4x 3cc transducers, each connects to a port of a 5-Gang Multiport. The middle port connects directly with a 20 drops, 60" Adset. The other 4 ports, each connects with a 6" Pressure Tubing with clamp. The 4 x 3cc transducers are individually connected to these tubings. The zeroing stopcock of transducer in port # 1 connects with a 12" Pressure tubing, with red tape for identification, It has a 60" &12" Pressure tubings connect to it via 2 separate 3-way red stopcocks. Port #2, transducer is connected with a 24" Pressure tubing identified with Yellow tape and a 3-Way yellow stopcock. Port # 4, with its transducer connects to a Blue taped 24" pressure tubing and a 3-Way blue stopcock. Port # 5 connects with a transducer. FDA UDI
Identifiers
- Catalog Number
- 686972 FDA UDI
- Primary DI / UDI-DI
- 00886333669721 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
Jewish Hospital-Open Heart 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 36c40bd1-c6f7-4199-afca-26dafcf40802 36 fields · synced May 30, 2026