Standard Starter Set - Standard Starter Set contains:Ear Clips - SenTec AG

Duns Number:480797856

Device Description: Standard Starter Set contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/inta Standard Starter Set contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)

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More Product Details

Catalog Number

-

Brand Name

Standard Starter Set

Version/Model Number

SSET

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

-

Product Code Details

Product Code

DPZ

Product Code Name

Oximeter, Ear

Device Record Status

Public Device Record Key

3b5fda2e-fc20-4144-afe8-785578a81d32

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SENTEC AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 38