Accessory; HTP1500 - IV Pole Bracket for HTP1500 - ADROIT MEDICAL SYSTEMS, INC.

Duns Number:795104769

Device Description: IV Pole Bracket for HTP1500

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More Product Details

Catalog Number

3103-0001

Brand Name

Accessory; HTP1500

Version/Model Number

IVPB-HTP1500

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Device Record Status

Public Device Record Key

00c4b96d-1832-49b7-ab8d-767cc73bde5a

Public Version Date

October 14, 2019

Public Version Number

1

DI Record Publish Date

October 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADROIT MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 93