AincA® - Manometer, Pressure, MRI Cond 3T, -40 to +80 cm - ANESTHESIA ASSOCIATES, INC.

Duns Number:002065670

Device Description: Manometer, Pressure, MRI Cond 3T, -40 to +80 cm H2O, 1/4" NPT-M Bottom-Mount, 2.5"Dia, Fro Manometer, Pressure, MRI Cond 3T, -40 to +80 cm H2O, 1/4" NPT-M Bottom-Mount, 2.5"Dia, Front Zero-Adj

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More Product Details

Catalog Number

00-199-MRI

Brand Name

AincA®

Version/Model Number

00-199-MRI

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

-

Product Code Details

Product Code

CAP

Product Code Name

MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

Device Record Status

Public Device Record Key

5e0f4c5c-f5b2-4476-8406-5d026cc4d698

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