Dispo Liner, 500mL For S401D, Suction Canister(30 pcs/box) - ATOM MEDICAL CORPORATION

Duns Number:690632047

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More Product Details

Catalog Number

60355

Brand Name

Dispo Liner, 500mL For S401D, Suction Canister(30 pcs/box)

Version/Model Number

60355

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"

-

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 Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

59e24b39-aa18-47bf-909e-e9507de3828c

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14942962603550

Quantity per Package

1

Contains DI Package

04942962603553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ATOM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 40