PICO70 - PICO70 23gx16mm Arterial blood sampler w. - Radiometer Medical ApS

Duns Number:308667539

Device Description: PICO70 23gx16mm Arterial blood sampler w. 23gx16mm needle (w/o needle cube), 1.5 mL, box o PICO70 23gx16mm Arterial blood sampler w. 23gx16mm needle (w/o needle cube), 1.5 mL, box of 100 units

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More Product Details

Catalog Number

956-546

Brand Name

PICO70

Version/Model Number

956-546

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2017

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)

-

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

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Device Record Status

Public Device Record Key

b199379c-ce94-4fd3-873c-e58d2acdea8a

Public Version Date

June 22, 2022

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RADIOMETER MEDICAL APS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 66