masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL - NXSTAGE MEDICAL, INC.

Duns Number:088013219

Device Description: SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGPLB

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More Product Details

Catalog Number

-

Brand Name

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET

Version/Model Number

D9-7005MGPLB

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"

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

-

Product Code Details

Product Code

FIE

Product Code Name

Needle, Fistula

Device Record Status

Public Device Record Key

00922807-a0c0-485d-8c00-8c04bd0f5e64

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NXSTAGE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 211