Halyard - ON-Q* Pain Relief System with SELECT-A-FLOW* and - Avanos Medical, Inc.

Duns Number:079375431

Device Description: ON-Q* Pain Relief System with SELECT-A-FLOW* and Bolus, 400 ml, 1-7 ml/hr + 3 ml bolus/30 ON-Q* Pain Relief System with SELECT-A-FLOW* and Bolus, 400 ml, 1-7 ml/hr + 3 ml bolus/30 min

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More Product Details

Catalog Number

CB005C

Brand Name

Halyard

Version/Model Number

46856

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K181360,K181360

Product Code Details

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Device Record Status

Public Device Record Key

1c0412c8-8d2e-41be-850b-dab38e1b18e2

Public Version Date

April 10, 2019

Public Version Number

1

DI Record Publish Date

April 02, 2019

Additional Identifiers

Package DI Number

30680651468568

Quantity per Package

5

Contains DI Package

10680651468564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221