ICU Medical - 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros™ - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros™ w/2 Red Caps, 20 Drop In-Line Drip Chamber, 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros™ w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers

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More Product Details

Catalog Number

CH3373

Brand Name

ICU Medical

Version/Model Number

CH3373

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

9a3c7761-3329-4172-9c6d-41c60a8b71d5

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Additional Identifiers

Package DI Number

10840619065802

Quantity per Package

50

Contains DI Package

00840619065805

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