Curaplex - CPAP/Capno Kit O2 Max 3-Set with Chemetron - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: CPAP/Capno Kit O2 Max 3-Set with Chemetron Connector, Adult Medium Mask, Guard Filter

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More Product Details

Catalog Number

670236-KIT

Brand Name

Curaplex

Version/Model Number

670236-KIT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Device Record Status

Public Device Record Key

4ec84daa-e1fb-4dbe-8fbf-76dec4056c01

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOUND TREE MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 471
2 A medical device with a moderate to high risk that requires special controls. 540
3 A medical device with high risk that requires premarket approval 3
U Unclassified 1