Sage Air Tap LC - Sage Air Tap Lift Compatible - SAGE PRODUCTS, LLC

Duns Number:054326178

Device Description: Sage Air Tap Lift Compatible

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More Product Details

Catalog Number

7287

Brand Name

Sage Air Tap LC

Version/Model Number

7287

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

FMP

Product Code Name

Protector, skin pressure

Device Record Status

Public Device Record Key

148c9a4e-eb31-4d60-86e4-aa063c894218

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

October 01, 2019

Additional Identifiers

Package DI Number

50618029720806

Quantity per Package

5

Contains DI Package

00618029720801

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