BCI - SMITHS MEDICAL MD, INC.

Duns Number:106712748

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More Product Details

Catalog Number

-

Brand Name

BCI

Version/Model Number

8044

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"

-

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

K941982,K941982

Product Code Details

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

5b33c93d-8854-40b9-b883-f776b3cec229

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

January 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITHS MEDICAL MD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 686
3 A medical device with high risk that requires premarket approval 2
U Unclassified 1