Ascom - TELLIGENCE BRIDGE SOFTWARE V5.3 - Ascom (Sweden) AB

Duns Number:356107490

Device Description: TELLIGENCE BRIDGE SOFTWARE V5.3

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More Product Details

Catalog Number

-

Brand Name

Ascom

Version/Model Number

NGTELL53-S

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)

-

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

IQA

Product Code Name

System, Environmental Control, Powered

Device Record Status

Public Device Record Key

1bc8a7c1-32d1-4bba-8e7b-698b60211b1e

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCOM (SWEDEN) AB" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 78