Catalog Number

DYNJ780ELB

Brand Name

Medline

Version/Model Number

DYNJ780ELB

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"

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

K042758,K042758

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

fab8ea4f-9c65-41e8-9d4a-f66bea87093d

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Package DI Number

20888277652498

Quantity per Package

100

Contains DI Package

10888277652491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE