Oxygen Tubing Swivel Connector Kit - This kit contains: 1 RES018 Oxygen Tubing - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: This kit contains: 1 RES018 Oxygen Tubing Connector - Swivel, 1 RES018ANS Oxygen Tubing Sw This kit contains: 1 RES018 Oxygen Tubing Connector - Swivel, 1 RES018ANS Oxygen Tubing Swivel Connector - Male to Female.

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More Product Details

Catalog Number

RES018KIT-1

Brand Name

Oxygen Tubing Swivel Connector Kit

Version/Model Number

RES018KIT-1

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

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

264de34b-7c86-4f11-a5d2-2880e06eeb8c

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