DALTON ASPIRATOR - ASPIRATOR, SUCTION DEVICE WITHOUT CANISTER. - DALTON MEDICAL CORPORATION

Duns Number:874709348

Device Description: ASPIRATOR, SUCTION DEVICE WITHOUT CANISTER.

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More Product Details

Catalog Number

-

Brand Name

DALTON ASPIRATOR

Version/Model Number

ASP

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

-

Prescription Use (Rx)

-

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

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Device Record Status

Public Device Record Key

867dcb32-f471-44ea-a915-bc83471de071

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DALTON MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 57