BCI - Fuzhou Blue Crystal Industrial Co.,Ltd.

Duns Number:421154057

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More Product Details

Catalog Number

-

Brand Name

BCI

Version/Model Number

BCI-E-CCTS-06

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

-

Prescription Use (Rx)

-

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Device Record Status

Public Device Record Key

818f50e9-d74c-46ce-82a9-4c3077262028

Public Version Date

December 21, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUZHOU BLUE CRYSTAL INDUSTRIAL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3