Curaplex - *Custom* Reno Fire Temp Bag for IFACT - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: *Custom* Reno Fire Temp Bag for IFACT

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More Product Details

Catalog Number

8600-01476

Brand Name

Curaplex

Version/Model Number

8600-01476

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)

-

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

OHO

Product Code Name

First aid kit without drug

Device Record Status

Public Device Record Key

26888db8-28dc-400f-b1fd-c1d0da6a7f9e

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

February 28, 2021

Additional Identifiers

Package DI Number

00810094572884

Quantity per Package

10

Contains DI Package

00810071631368

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"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