NA - Airrapy Pillowed Air Cover QLT-1p - CARILEX MEDICAL, INC.

Duns Number:658863238

Device Description: Airrapy Pillowed Air Cover QLT-1p

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

S2002-A020

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

Public Device Record Key

1d84afc5-e18b-4c84-a562-7badc46351b7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 22, 2017

Additional Identifiers

Package DI Number

04713616092265

Quantity per Package

10

Contains DI Package

04713616093316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CARILEX MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 144