HUDSON RCI - CONCHAPAK Sterile Water, 1650 mL with Minimal - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: CONCHAPAK Sterile Water, 1650 mL with Minimal Compliance CONCHA COLUMN

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More Product Details

Catalog Number

385-40

Brand Name

HUDSON RCI

Version/Model Number

IPN044288

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

K993355,K993355

Product Code Details

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Record Status

Public Device Record Key

d4fb8648-234d-4c0b-bf27-b6dc91f56846

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

14026704597632

Quantity per Package

6

Contains DI Package

04026704597635

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