SteriCare Solutions - USP Normal Saline, 500 mL Bottle - NURSE ASSIST, INC.

Duns Number:869434464

Device Description: USP Normal Saline, 500 mL Bottle

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More Product Details

Catalog Number

-

Brand Name

SteriCare Solutions

Version/Model Number

6280

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083042,K083042

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

7dc698cb-09e0-4452-819c-c2cfdf191d9c

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NURSE ASSIST, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 48
U Unclassified 7