Catalog Number

D208-700/FC100

Brand Name

Access Medical Probes

Version/Model Number

D-208-700/FC100

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

K071977,K071977

Product Code

FMT

Product Code Name

Warmer, Infant Radiant

Public Device Record Key

72ca661c-c793-48ad-aad0-208b75dcb1dd

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

10854758006206

Quantity per Package

50

Contains DI Package

00854758006209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-