ICU Medical - 137" (348 cm) 60 Drop 150 ml Burette Set (Clave™, - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 137" (348 cm) 60 Drop 150 ml Burette Set (Clave™, Shut-Off) w/3 Clave™, Remv 4-Way Stopcoc 137" (348 cm) 60 Drop 150 ml Burette Set (Clave™, Shut-Off) w/3 Clave™, Remv 4-Way Stopcock, Spin Luer w/Filter Cap, 1 Ext, Drop-In Ext Set w/2 Clave™ (1 Remv)

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More Product Details

Catalog Number

B33966

Brand Name

ICU Medical

Version/Model Number

B33966

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

K964435,K964435

Product Code Details

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Device Record Status

Public Device Record Key

c459970e-8b57-4696-8cc6-5ef05717b814

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Additional Identifiers

Package DI Number

10887709122274

Quantity per Package

25

Contains DI Package

00887709122277

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