CMI - Vacuum Pump, PN 101A, Non-Electrical (Manual), - UTAH MEDICAL PRODUCTS, INC.

Duns Number:094651270

Device Description: Vacuum Pump, PN 101A, Non-Electrical (Manual), Blue, Can be Autoclaved & EO Gas Sterilized

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More Product Details

Catalog Number

101A

Brand Name

CMI

Version/Model Number

Vacuum Pump

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K895446

Product Code Details

Product Code

HDB

Product Code Name

Extractor, Vacuum, Fetal

Device Record Status

Public Device Record Key

1031933c-fc6c-4cf4-aca0-4a35ee4d73e8

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UTAH MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 274