Tablo(R) Cartridge - Tablo X Cartridge with Needleless Infusion Ports - OUTSET MEDICAL, INC.

Duns Number:788744477

Device Description: Tablo X Cartridge with Needleless Infusion Ports

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More Product Details

Catalog Number

PN-0004220

Brand Name

Tablo(R) Cartridge

Version/Model Number

PN-0005643

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

K210782,K210782

Product Code Details

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Device Record Status

Public Device Record Key

a43e394c-dcc9-4415-bcb3-69fc64284a1d

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Additional Identifiers

Package DI Number

10850001011218

Quantity per Package

6

Contains DI Package

00850001011211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"OUTSET MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9