Catalog Number

1105

Brand Name

BIONIX DEVELOPMENT CORPORATION

Version/Model Number

SP-21105

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123411

Product Code

PDH

Product Code Name

blanket, neonatal phototherapy

Public Device Record Key

63136f05-c0f4-46d4-a927-7f788b3716d1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-