HYDROVEN - HYDROVEN 3 PUMP USA/CA - HUNTLEIGH HEALTHCARE LIMITED

Duns Number:217207083

Device Description: HYDROVEN 3 PUMP USA/CA

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More Product Details

Catalog Number

510003

Brand Name

HYDROVEN

Version/Model Number

510003

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

-

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

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

9dcf0b85-9b20-4211-8451-c3b42141621b

Public Version Date

October 15, 2021

Public Version Number

3

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HUNTLEIGH HEALTHCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 159