Aspirator - 2510 EMERGENCY ASPIRATOR(1) - VITALOGRAPH (IRELAND) LIMITED

Duns Number:219683489

Device Description: 2510 EMERGENCY ASPIRATOR(1)

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More Product Details

Catalog Number

-

Brand Name

Aspirator

Version/Model Number

2510

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

BTA

Product Code Name

PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Device Record Status

Public Device Record Key

2a2bf9e7-c6c1-46ba-88b6-588b7232b56c

Public Version Date

August 23, 2018

Public Version Number

2

DI Record Publish Date

May 09, 2018

Additional Identifiers

Package DI Number

05099169251007

Quantity per Package

1

Contains DI Package

15099169251004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VITALOGRAPH (IRELAND) LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 189