Adapter, Straight 22mm O/D - 15mm I/D - Adapter, Straight 22mm O/D - 15mm I/D (50/pack) - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Adapter, Straight 22mm O/D - 15mm I/D (50/pack)

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More Product Details

Catalog Number

HSK962A

Brand Name

Adapter, Straight 22mm O/D - 15mm I/D

Version/Model Number

HSK962A

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

-

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

Public Device Record Key

1f9cd3f7-6957-4174-9699-d2c852fb8417

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNSET HEALTHCARE SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 68