Lynn Medical - Ambulatory Kit - Ambulatory Monitoring Kit - AccuSensor 690-005 - Lynn Medical Instrument Co.

Duns Number:058810771

Device Description: Ambulatory Monitoring Kit - AccuSensor 690-005

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More Product Details

Catalog Number

311110

Brand Name

Lynn Medical - Ambulatory Kit

Version/Model Number

311110

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"

Yes

For Single-Use

Yes

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

0ea11d7b-ea9f-4152-960f-f7d8c8c97a5a

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Additional Identifiers

Package DI Number

10851491007262

Quantity per Package

20

Contains DI Package

00851491007265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"LYNN MEDICAL INSTRUMENT CO." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6