Atellica® VTR Syringes - 1mL Vented Luer Slip Syringe, 25g x 5/8" Needle, - WESTMED, INC.

Duns Number:092673953

Device Description: 1mL Vented Luer Slip Syringe, 25g x 5/8" Needle, ~25IU Balanced Heparin, Vented Tip Cap, Q 1mL Vented Luer Slip Syringe, 25g x 5/8" Needle, ~25IU Balanced Heparin, Vented Tip Cap, Q-Cork (Private Label)

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More Product Details

Catalog Number

-

Brand Name

Atellica® VTR Syringes

Version/Model Number

11561342

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

K931924,K931924

Product Code Details

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

5320b07f-fd72-49ab-8ca7-608bba943453

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

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