Sage Multi-Position MATS - Sage Multi-Position MATS Mobile Air Transfer - SAGE PRODUCTS, LLC

Duns Number:054326178

Device Description: Sage Multi-Position MATS Mobile Air Transfer System

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More Product Details

Catalog Number

3232

Brand Name

Sage Multi-Position MATS

Version/Model Number

3232

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Device Record Status

Public Device Record Key

fc335083-d3c7-438b-b5a1-ef0f7567e144

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

50618029760864

Quantity per Package

5

Contains DI Package

00618029760869

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"SAGE PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 12