Rescuer BVM Manual Resuscitator 4000-U-P

GUDID B0024000UP3

Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir bag, #5 cushion mask, 2 m crush proof oxygen tubing (universal connector) and attached 0-20 cmH2O PEEP valve.

B.L.S. Systems Limited

Pulmonary resuscitator, manual, single-use
Primary Device IDB0024000UP3
NIH Device Record Key534e2110-3ab0-41d3-92fb-f554196e3f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRescuer BVM Manual Resuscitator
Version Model Number4000-U-P
Catalog Number4000-U-P
Company DUNS200103823
Company NameB.L.S. Systems Limited
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone19053391069
Emailtedreesor@blssystemsltd.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0024000UP0 [Primary]
HIBCCB0024000UP3 [Package]
Contains: B0024000UP0
Package: case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-04
Device Publish Date2019-10-25

On-Brand Devices [Rescuer BVM Manual Resuscitator]

B0024050U3Rescuer disposable adult manual resuscitator with pressure release valve, 2900 ml bag reservoir,
B00240506Rescuer disposable adult manual resuscitator with pressure release valve, 2900 mL reservoir, #5
B0024025U0Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 mask, 2m crush proof oxy
B00240256Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 m cru
B00240100Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush pro
B00240000Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask and 2 m
B0024050UP3Rescuer branded adult disposable BVM manual resuscitator with system pressure relif valve, 2900
B0024025UP3Rescuer Infant sized disposable BVM manual resuscitator with 800 mL reservoir bag, #1 cushion ma
B0024010UP3Rescuer branded child disposable BVM Manual Resuscitator with 2900 mL reservoir, #3 cushion mask
B0024000UP3Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir bag, #5 cushion ma

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