Clear-View Multi-site Subcutaneous Infusion Set - 27G x 4mm x 36" Clear-View Multi-site "Sub-Q" - NORFOLK MEDICAL

Duns Number:013861471

Device Description: 27G x 4mm x 36" Clear-View Multi-site "Sub-Q" Infusion Set (2 Sites)

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More Product Details

Catalog Number

SCIG53423A

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,K870188

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

49c24b48-24be-42ac-a9a9-e43db766312e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

M991SCIG53423A2

Quantity per Package

6

Contains DI Package

M991SCIG53423A1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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