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Dt-Dl60-1 W/Bifurcated Ad Set

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
DT-DL60-1 W/BIFURCATED AD SET FDA UDI
Generic Name
Invasive-pressure external transducer, single-use FDA UDI
Device Name
2-way 20 drops, 60" Adset, with 1 channel connects to a 3cc transducer, 3-way red stopcock, a 48" Pressure Tubing, a 3-way white stopcock and a 12" Pressure Tubing. The 2nd channel connects with a Critiflo. The 3-way red stopcock from Channel 1 is connected to the Critiflo which is connected to a 48" Pressure tubing, a 3-way white stopcock and a 12" Pressure tubing. It also has a separately packed 3x male & 1x female Protective caps and a Colour Set label. FDA UDI
Model / Reference
682147 FDA UDI
Description
2-way 20 drops, 60" Adset, with 1 channel connects to a 3cc transducer, 3-way red stopcock, a 48" Pressure Tubing, a 3-way white stopcock and a 12" Pressure Tubing. The 2nd channel connects with a Critiflo. The 3-way red stopcock from Channel 1 is connected to the Critiflo which is connected to a 48" Pressure tubing, a 3-way white stopcock and a 12" Pressure tubing. It also has a separately packed 3x male & 1x female Protective caps and a Colour Set label. FDA UDI

Identifiers

Catalog Number
682147 FDA UDI
Primary DI / UDI-DI
00886333621477 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

Dt-Dl60-1 W/Bifurcated Ad Set 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 48ecb046-6acd-48b4-a7c1-4585bffa78d3 36 fields · synced Jun 8, 2026