Manual resuscitator, neonatal

WHO list of priority medical devices
Reproductive, maternal, newborn and child health (2015)
Service type
Resuscitative
Life course
Childbirth
Neonatal
Sex
All
Service delivery platforms
3. Pre-hospital emergency services
4. General outpatient services and outreach
5. First-level (district) hospital services
6. Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Emergency care
General surgery
Inpatient care
Intensive care
Long-term care
Medical imaging
Outpatient care
Pre-hospital care
Rehabilitation
Specialized diagnostics
Specialized surgery
Specialized treatment
Type of medical device
Medical equipment
EMDN related* code(s)
R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS
https://webgate.ec.europa.eu/dyna2/emdn
GMDN related* code(s)
36086 Pulmonary resuscitator, manual, single-use
37709 Breathing circuit bag, reusable
https://gmdnagency.org
© GMDN Agency 2005-2021
UMDNS related* code(s)
17592 Resuscitators Pulmonary Manual Disposable
13367 Resuscitators Pulmonary Manual
17170 Masks Resuscitator
10486 Breathing Bags
https://www.ecri.org/solutions/umdns
© ECRI. All rights reserved
UNSPSC related* code(s)
42272301 Manual resuscitators
42272300 Resuscitation supplies
https://store.unspsc.org/collections/codeset-downloads
* The codes shown in this section were observed and retrieved from public databases and complemented with the input of Nomenclature Agencies. More information
Capital
Yes
Reusable
Yes
Requirements
None
Level of technical knowledge
Specialized clinical
Regulatory classification (EU)
Class IIa
Directive 93/42/EEC
Regulation (EU) 2017/745
Regulatory classification (FDA)
Class II
PMD books
Kit or set
It is a component of the basic resuscitation kit.
WHO Tech Specs
Specific details
NO
Quality product standards
ISO 13485:2012 ISO 10651-4:2002 ISO 10993-1:2009 ISO 10993-5:2009 ISO 10993-10:2009 ISO 14971 ISO 5356-1:2004 BS EN 980:2008 ISO 15223-1:2012 BS EN 1041:
Decommissioning
WHO assessed product
https://apps.who.int/iris/bitstream/handle/10665/206540/9789241510264_eng.pdf?sequence=1&isAllowed=y
Quality product standards
ISO 13485:2012 ISO 10651-4:2002 ISO 10993-1:2009 ISO 10993-5:2009 ISO 10993-10:2009 ISO 14971 ISO 5356-1:2004 BS EN 980:2008 ISO 15223-1:2012 BS EN 1041:
WHO assessed product