Portex - Smiths Medical International Ltd

Duns Number:215591523

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More Product Details

Catalog Number

-

Brand Name

Portex

Version/Model Number

C45041803D-NL

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

-

Product Code Details

Product Code

BSJ

Product Code Name

MASK, GAS, ANESTHETIC

Device Record Status

Public Device Record Key

562cb56b-54aa-4404-ab08-ccf465b5e18a

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2017

Additional Identifiers

Package DI Number

35019517122101

Quantity per Package

15

Contains DI Package

15019517122107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"SMITHS MEDICAL INTERNATIONAL LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 332
2 A medical device with a moderate to high risk that requires special controls. 431