Single Patient Use Resuscitator - SPUR II Ped Bag Res, Pop-off, Tod Mask, Exp Filter - Ambu A/S

Duns Number:305682023

Device Description: SPUR II Ped Bag Res, Pop-off, Tod Mask, Exp Filter

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More Product Details

Catalog Number

530613048

Brand Name

Single Patient Use Resuscitator

Version/Model Number

530613048

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

edb5feec-720f-4a0e-8d86-dbc2e9af61d2

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 2021

Additional Identifiers

Package DI Number

05707480154425

Quantity per Package

6

Contains DI Package

05707480154432

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