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Dtx(tm) Plus Dt-Dl60

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
DTX(TM) PLUS DT-DL60 FDA UDI
Generic Name
Invasive-pressure external transducer, single-use FDA UDI
Device Name
a 3-way 20 drops adset with 60" tube length on each channel. 1 chnnel is connected with a 3cc transducer which is connected with a 48" pressure tubing and a 12" tubing. The sideport of the transducer is connected to a critiflo. Other end of the critiflo is connected to the 2nd channel of the Adset . The Critiflo also connected with a 48" and a 12" pressure tubings. The 3rd channel is left open. There is a separately packed 3xmale & a female protective caps. FDA UDI
Model / Reference
682028 FDA UDI
Description
a 3-way 20 drops adset with 60" tube length on each channel. 1 chnnel is connected with a 3cc transducer which is connected with a 48" pressure tubing and a 12" tubing. The sideport of the transducer is connected to a critiflo. Other end of the critiflo is connected to the 2nd channel of the Adset . The Critiflo also connected with a 48" and a 12" pressure tubings. The 3rd channel is left open. There is a separately packed 3xmale & a female protective caps. FDA UDI

Identifiers

Catalog Number
682028 FDA UDI
Primary DI / UDI-DI
00886333620289 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-Dl60 by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive-pressure external transducer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Critical Care Systems Singapore Pte. Ltd.

Sources (1)

  • FDA UDI 2ccd151d-3841-4baf-833d-9f36421f3d98 36 fields · synced May 30, 2026