MICROTEK - AUTO EXTERNAL DEFIBRILLATION, 1-EACH - Microtek Medical Inc.

Duns Number:106908437

Device Description: AUTO EXTERNAL DEFIBRILLATION, 1-EACH

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More Product Details

Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K950769,K950769

Product Code Details

Product Code

CBP

Product Code Name

Valve, non-rebreathing

Device Record Status

Public Device Record Key

66b5e92a-7386-4b78-b857-cc84a7070fb8

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

March 17, 2017

Additional Identifiers

Package DI Number

50748426074407

Quantity per Package

10

Contains DI Package

00748426120383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MICROTEK MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 919