Catalog Number

2001

Brand Name

Sapphire Suction Reservoir

Version/Model Number

2001 Pouch

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K905733,K905733

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Public Device Record Key

6219c447-086e-46d7-b315-a3f5a8a9051b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 10, 2017

Package DI Number

00854373007087

Quantity per Package

10

Contains DI Package

00854373007070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box