ambIT - St. Luke's Pain Control System - SUMMIT MEDICAL PRODUCTS, INC.

Duns Number:831704841

Device Description: St. Luke's Pain Control System

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More Product Details

Catalog Number

220469

Brand Name

ambIT

Version/Model Number

220469

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

OFQ

Product Code Name

Anesthesia Kit

Device Record Status

Public Device Record Key

7f0069c9-c750-44da-8162-c985fc1ca76b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

20857595005309

Quantity per Package

5

Contains DI Package

00857595005305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SUMMIT MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 70