Catalog Number

SG 066-2N-2P

Brand Name

SG 066-2N-2P 1 liter reservoir bag

Version/Model Number

SG 066-2N-2P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BTC

Product Code Name

Bag, Reservoir

Public Device Record Key

a61a633c-17e8-4daa-b84a-25c426a55346

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 31, 2019

Package DI Number

M996SG0662N2P4

Quantity per Package

25

Contains DI Package

M996SG0662N2P0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ziplock Bag