AincA® - Mask, RBS Type, 22mmF, Size 2 Small Child, - ANESTHESIA ASSOCIATES, INC.

Duns Number:002065670

Device Description: Mask, RBS Type, 22mmF, Size 2 Small Child, Non-Conductive Black Neoprene

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More Product Details

Catalog Number

LF-141-2

Brand Name

AincA®

Version/Model Number

LF-141-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

BSJ

Product Code Name

MASK, GAS, ANESTHETIC

Device Record Status

Public Device Record Key

fba633ae-f747-4fd1-84cc-f16e950c3be4

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