Identity
- Trade Name
- DTX(TM) PLUS DT-4812R FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer which is assembled with a damping device, a 48" Pressure tubing, a 3-Way white stopcock and a 12" Pressure Tubing. It also includes a separately packed 2x male protective caps and a Label Set. FDA UDI
- Model / Reference
- 682133 FDA UDI
- Description
- A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer which is assembled with a damping device, a 48" Pressure tubing, a 3-Way white stopcock and a 12" Pressure Tubing. It also includes a separately packed 2x male protective caps and a Label Set. FDA UDI
Identifiers
- Catalog Number
- 682133 FDA UDI
- Primary DI / UDI-DI
- 00886333621330 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Invasive-pressure external transducer, single-use 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-pressure external transducer, single-use
Dtx(tm) Plus Dt-4812r 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 ce1b6d10-275e-4270-b037-df085cabfbf9 36 fields · synced Jun 8, 2026