Single Patient Use Resuscitator - SPUR II Ped Tube Res, Pop, Tod Mask, Mano, PEEP, - Ambu A/S

Duns Number:305682023

Device Description: SPUR II Ped Tube Res, Pop, Tod Mask, Mano, PEEP, Exp Filter

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

531613051

Brand Name

Single Patient Use Resuscitator

Version/Model Number

531613051

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Device Record Status

Public Device Record Key

ee5d3535-992e-45c7-9fa9-44cd4ef0d1e3

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 2021

Additional Identifiers

Package DI Number

05707480154463

Quantity per Package

6

Contains DI Package

05707480154470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"AMBU A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 309