Identity
- Trade Name
- DTX(TM) PLUS DT-4812D FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- pressure Monitoring Kits with a 2-way Adset connected with 2 3cc transducers and tube length of 120" per channel. It also includes 2 package sets of 2 male protective caps and a label set, FDA UDI
- Model / Reference
- 682007 FDA UDI
- Description
- pressure Monitoring Kits with a 2-way Adset connected with 2 3cc transducers and tube length of 120" per channel. It also includes 2 package sets of 2 male protective caps and a label set, FDA UDI
Identifiers
- Catalog Number
- 682007 FDA UDI
- Primary DI / UDI-DI
- 00886333620074 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-4812d 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 4047e6fa-d70c-42aa-a161-21e4e20c4dfb 36 fields · synced Jun 8, 2026