Cannulaide - Cannulaide Size 2 - SALTER LABS

Duns Number:022721133

Device Description: Cannulaide Size 2

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More Product Details

Catalog Number

CA102-0-25

Brand Name

Cannulaide

Version/Model Number

CA102-0-25

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

K143700

Product Code Details

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Record Status

Public Device Record Key

116e8936-da95-4391-9e62-ac9025ebb416

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134