PRiO-mini 84 Location Keyguard - This keyguard specifically designed to work with - PRENTKE ROMICH COMPANY

Duns Number:080143399

Device Description: This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO- This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO-mini.

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More Product Details

Catalog Number

-

Brand Name

PRiO-mini 84 Location Keyguard

Version/Model Number

17656

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

82d46789-89a7-4a74-b74a-c198b524d594

Public Version Date

February 25, 2019

Public Version Number

1

DI Record Publish Date

January 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRENTKE ROMICH COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 198