Catalog Number

7000-AD

Brand Name

Rescuer 7000-AD Replacement Suction Canister kit

Version/Model Number

7000-AD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OFO

Product Code Name

Airway Suction Kit

Public Device Record Key

5c5a6968-71a6-46d9-9da5-24f60ef3e9c8

Public Version Date

November 02, 2018

Public Version Number

1

DI Record Publish Date

October 02, 2018

Package DI Number

B0027000AD9

Quantity per Package

80

Contains DI Package

B0027000AD0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case