HUDSON RCI - AQUAPAK Sterile Water for Inhalation 440 mL w/ - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: AQUAPAK Sterile Water for Inhalation 440 mL w/ 028 Nebulizer Adaptor

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More Product Details

Catalog Number

044-28

Brand Name

HUDSON RCI

Version/Model Number

IPN040643

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

OGG

Product Code Name

Humidifier nebulizer kit

Device Record Status

Public Device Record Key

8c5f88c0-f595-4066-b8c1-399e7dc4fb26

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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