AincA® - Jet Ventilator Extension Hose, 1ft, LuerF Lock x - ANESTHESIA ASSOCIATES, INC.

Duns Number:002065670

Device Description: Jet Ventilator Extension Hose, 1ft, LuerF Lock x LuerM Lock, PVC/Chrome Brass

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More Product Details

Catalog Number

00-325-LP-EXT1

Brand Name

AincA®

Version/Model Number

00-325-LP-EXT1

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

K921926

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, emergency, powered (resuscitator)

Device Record Status

Public Device Record Key

6db292ea-fcb9-4994-9ab0-4be0523a03f3

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANESTHESIA ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 561
2 A medical device with a moderate to high risk that requires special controls. 135