Vial Set - 10ml Vial Set - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: 10ml Vial Set

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More Product Details

Catalog Number

ASPP99DPTVL

Brand Name

Vial Set

Version/Model Number

ASPP99DPTVL

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"

-

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

FMH

Product Code Name

Container, Specimen, Sterile

Device Record Status

Public Device Record Key

666b4fb6-054f-46d0-aea1-d9dcaf801b91

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Additional Identifiers

Package DI Number

20886333220988

Quantity per Package

40

Contains DI Package

00886333220984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205