NA - Canister for VT•100 - 1000ml lock - CARILEX MEDICAL, INC.

Duns Number:658863238

Device Description: Canister for VT•100 - 1000ml lock

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

S1001-6040

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

58c912c0-89da-40e8-bfa6-36b34a1f7d8d

Public Version Date

March 31, 2020

Public Version Number

4

DI Record Publish Date

March 22, 2017

Additional Identifiers

Package DI Number

04713616090261

Quantity per Package

5

Contains DI Package

04713616093637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CARILEX MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 144