DEVICE: The BAG II Resuscitator Adult mask #5 w/inf.port (07045432067972)
Device Identifier (DI) Information
The BAG II Resuscitator Adult mask #5 w/inf.port
845151
In Commercial Distribution
845151
Laerdal Medical AS
845151
In Commercial Distribution
845151
Laerdal Medical AS
The BAG II are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The SIMPLIFY COMPACT RESUSCITATOR provided in reusable models and in the disposable models.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
36086 | Pulmonary resuscitator, manual, single-use |
A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTM | Ventilator, Emergency, Manual (Resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a40e7e43-18b3-4acf-9ccc-30e056edbfc2
March 29, 2018
2
October 19, 2015
March 29, 2018
2
October 19, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07045432068047 | 12 | 07045432067972 | In Commercial Distribution | Carton |
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
[?]
(800)4311055
customerservice@laerdal.com (877) 523-7325
customerservice@laerdal.com
customerservice@laerdal.com (877) 523-7325
customerservice@laerdal.com