CARDINAL HEALTH - JP 3-SPRING RES W/SILICONE ADAPTERS - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: JP 3-SPRING RES W/SILICONE ADAPTERS

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More Product Details

Catalog Number

SU130-475

Brand Name

CARDINAL HEALTH

Version/Model Number

SU130-475

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

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Record Status

Public Device Record Key

0249b022-7afc-4a71-b9db-13dc15485e70

Public Version Date

October 24, 2019

Public Version Number

1

DI Record Publish Date

October 16, 2019

Additional Identifiers

Package DI Number

20192253016465

Quantity per Package

6

Contains DI Package

10192253016468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40