Catalog Number

2003U

Brand Name

Bio-Med Devices, Inc.

Version/Model Number

2003U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K925982

Product Code

MOD

Product Code Name

Accessory To Continuous Ventilator (Respirator)

Public Device Record Key

0a07f059-b4fa-442d-874e-f6132f308ff4

Public Version Date

October 14, 2019

Public Version Number

1

DI Record Publish Date

October 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-