CAPIOX - Device Holder - TERUMO CORPORATION

Duns Number:690543319

Device Description: Device Holder

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More Product Details

Catalog Number

XX*XH081

Brand Name

CAPIOX

Version/Model Number

XX*XH081

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

KRI

Product Code Name

ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

855cf5ee-ff33-444b-8f83-15f2c88143fa

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Additional Identifiers

Package DI Number

54987350744598

Quantity per Package

10

Contains DI Package

04987350744593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TERUMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 364
3 A medical device with high risk that requires premarket approval 29