Level 1 - SMITHS MEDICAL MD, INC.

Duns Number:106712748

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More Product Details

Catalog Number

-

Brand Name

Level 1

Version/Model Number

SC-3

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

BK860023,BK860023,BK860023,BK860023

Product Code Details

Product Code

KZL

Product Code Name

DEVICE, WARMING. BLOOD AND PLASMA

Device Record Status

Public Device Record Key

5eab7d5a-9218-4346-a8a8-9457f2957898

Public Version Date

August 17, 2018

Public Version Number

4

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

30695085400305

Quantity per Package

160

Contains DI Package

20695085400308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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