384 ct Milk Bags (8 Softpacks) - 384 ct Milk Bags (8 Softpacks) - EXPLORAMED NC7, INC.

Duns Number:050917861

Device Description: 384 ct Milk Bags (8 Softpacks)

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More Product Details

Catalog Number

B38459

Brand Name

384 ct Milk Bags (8 Softpacks)

Version/Model Number

B38459

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

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

f1024176-22a5-4ea8-ab2a-9420fc6e56de

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXPLORAMED NC7, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 57