CRITICATH SP5507S TD CATHETER - Catheter 7.5 FR, 5 Lumen, length 110cm - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: Catheter 7.5 FR, 5 Lumen, length 110cm

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More Product Details

Catalog Number

680359

Brand Name

CRITICATH SP5507S TD CATHETER

Version/Model Number

680359

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KRB

Product Code Name

Probe, Thermodilution

Device Record Status

Public Device Record Key

ef2be73b-c484-4dd6-9e68-1e860b2cdf11

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50886333603591

Quantity per Package

20

Contains DI Package

00886333603596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Tray

"ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 392