PNSMX Resupply kits - Resupply Kit 21mm for PNSMX Pump - MEDELA, INC.

Duns Number:052002029

Device Description: Resupply Kit 21mm for PNSMX Pump

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More Product Details

Catalog Number

-

Brand Name

PNSMX Resupply kits

Version/Model Number

101045230

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OHH

Product Code Name

Breast Pump Kit

Device Record Status

Public Device Record Key

eae036ca-c0e1-4b2f-af0a-08a8addf66dc

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDELA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 244