Stratus Pump 5.1 (110 V) - 110V Stratus Pump 5.1 - SIZEWISE RENTALS, L.L.C.

Duns Number:967025602

Device Description: 110V Stratus Pump 5.1

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More Product Details

Catalog Number

-

Brand Name

Stratus Pump 5.1 (110 V)

Version/Model Number

8741153

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

c3a75d35-d842-41fb-97f4-408905300b21

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

February 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIZEWISE RENTALS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 130
2 A medical device with a moderate to high risk that requires special controls. 139