MED-RX - MED-RX ENTERAL FEEDING TUBE, 8 FR X 16", - Canadian Hospital Specialties Limited

Duns Number:240992693

Device Description: MED-RX ENTERAL FEEDING TUBE, 8 FR X 16", POLYURETHANE, PEDIATRIC

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More Product Details

Catalog Number

54-1680R

Brand Name

MED-RX

Version/Model Number

54-1680R

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

K100700,K100700

Product Code Details

Product Code

FPD

Product Code Name

Tube, Feeding

Device Record Status

Public Device Record Key

72d4c153-258e-4229-a2f0-db42f0aca6eb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2016

Additional Identifiers

Package DI Number

50628725003011

Quantity per Package

10

Contains DI Package

00628725003016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CORRUGATE CASE

"CANADIAN HOSPITAL SPECIALTIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 15