DEVICE: Mark IV Baby Resuscitator (05707480035243)
Device Identifier (DI) Information
Mark IV Baby Resuscitator
299006000
In Commercial Distribution
299006000
Ambu A/S
299006000
In Commercial Distribution
299006000
Ambu A/S
Resuscitator with Reservoir Bag
Device Characteristics
MR Conditional | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36690 | Cardiopulmonary resuscitation kit, reusable |
A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OEV | Cardiopulmonary resuscitation aid kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between -18 and 50 Degrees Celsius |
Storage Environment Temperature: between -18 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Baby |
Device Record Status
41c77e35-5a62-40a9-8845-fc09c9fe7f78
September 24, 2024
3
December 19, 2016
September 24, 2024
3
December 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05707480019564 | 12 | 05707480035243 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+14107686464
Purchase_orders@ambuUSA.com
Purchase_orders@ambuUSA.com