AincA - Jet Ventilator Replacement Hose 2ft, MRI, Outlet, - ANESTHESIA ASSOCIATES, INC.

Duns Number:002065670

Device Description: Jet Ventilator Replacement Hose 2ft, MRI, Outlet, 1/8" NPT-M x LuerM Lock

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More Product Details

Catalog Number

00-325-MRI-LP

Brand Name

AincA

Version/Model Number

00-325-MRI-LP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

33455928-bd69-4713-9154-3b6df857767f

Public Version Date

September 25, 2020

Public Version Number

5

DI Record Publish Date

August 19, 2016

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