15mmF / 30mmM Adapter - PULMODYNE INC

Duns Number:030619483

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More Product Details

Catalog Number

-

Brand Name

15mmF / 30mmM Adapter

Version/Model Number

313-8184

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

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

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Device Record Status

Public Device Record Key

741ae2fd-0489-472f-941b-d627ecaf7bd3

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

December 31, 2017

Additional Identifiers

Package DI Number

10841470109971

Quantity per Package

50

Contains DI Package

00841470109974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PULMODYNE INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 491