Pulset™ 3CC Syringe, 23G X 1", Safety Tip, 25U BH - Pulset™ 3CC Syringe, 23G X 1" (0.6 X 25 MM), - WESTMED, INC.

Duns Number:092673953

Device Description: Pulset™ 3CC Syringe, 23G X 1" (0.6 X 25 MM), Safety Tip, 25U BH

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More Product Details

Catalog Number

-

Brand Name

Pulset™ 3CC Syringe, 23G X 1", Safety Tip, 25U BH

Version/Model Number

3303-91

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

-

Product Code Details

Product Code

CBT

Product Code Name

Arterial Blood Sampling Kit

Device Record Status

Public Device Record Key

f0e00df0-004e-472c-9953-f13e1473c424

Public Version Date

May 03, 2022

Public Version Number

3

DI Record Publish Date

March 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320