HUDSON RCI - UP-DRAFT II OPTI-NEB NEBULIZER W/TEE - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: UP-DRAFT II OPTI-NEB NEBULIZER W/TEE

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More Product Details

Catalog Number

1737

Brand Name

HUDSON RCI

Version/Model Number

IPN042762

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"

Yes

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

K760489,K760489

Product Code Details

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Device Record Status

Public Device Record Key

cb86c658-829f-44f8-968a-997cbdb81c37

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

24026704595475

Quantity per Package

50

Contains DI Package

04026704595471

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26