Firefly IPA Bottle - 99% IPA bottle for use with the Firefly system - PURACATH MEDICAL, INC

Duns Number:963236661

Device Description: 99% IPA bottle for use with the Firefly system

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More Product Details

Catalog Number

-

Brand Name

Firefly IPA Bottle

Version/Model Number

40595

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2016

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

-

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

KDJ

Product Code Name

Set, Administration, For Peritoneal Dialysis, Disposable

Device Record Status

Public Device Record Key

f6e9086d-8378-4744-9b4b-f0b19772fbb4

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

November 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PURACATH MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2