SampLok® Adapter Cap - SampLok® Adaptor Cap, Clear, Bulk, Non-sterile; - ITL ASIA PACIFIC SDN. BHD.

Duns Number:597723837

Device Description: SampLok® Adaptor Cap, Clear, Bulk, Non-sterile; Intended to facilitate collection of blood SampLok® Adaptor Cap, Clear, Bulk, Non-sterile; Intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes

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More Product Details

Catalog Number

A100706

Brand Name

SampLok® Adapter Cap

Version/Model Number

A100706

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

K000777,K000777

Product Code Details

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

76a16c84-e689-42cb-960d-f79618cdfd74

Public Version Date

April 23, 2019

Public Version Number

2

DI Record Publish Date

March 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ITL ASIA PACIFIC SDN. BHD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 5