ICU Medical - 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros™ - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros™ w/Red Cap, 20 Drop In-Line Drip Chamber, 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros™ w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger

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More Product Details

Catalog Number

CH3639

Brand Name

ICU Medical

Version/Model Number

CH3639

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

K081361,K081361

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

7b9beac1-c936-46d8-8c6c-8522ced98a8a

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Additional Identifiers

Package DI Number

10887709085715

Quantity per Package

50

Contains DI Package

00887709085718

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"ICU MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4887