Clear-View Multi-site Subcutaneous Infusion Set - 27G x 6mm x 36" Clear-View Multi-site "Sub-Q" - NORFOLK MEDICAL

Duns Number:013861471

Device Description: 27G x 6mm x 36" Clear-View Multi-site "Sub-Q" Infusion Set (4 Sites)

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More Product Details

Catalog Number

SCIG33136

Brand Name

Clear-View Multi-site Subcutaneous Infusion Set

Version/Model Number

ClearView™MS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K870188

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

c46e2cd7-f7d3-4719-9349-358c448c14d1

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORFOLK MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 239