Catalog Number

-

Brand Name

CLEARLITE, ANESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, RED SEAL, 22F

Version/Model Number

7296000

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

Yes

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

-

FDA Premarket Submission

-

Product Code

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

0322974c-1900-461a-9552-2ceed07660c0

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Package DI Number

05030267153299

Quantity per Package

20

Contains DI Package

05030267152292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-