Rescuer Child BVM Manual Rescusitator 4010U

GUDID B0024010U3

Rescuer disposable Child manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush proof oxygen tubing with universal style connector

B.L.S. Systems Limited

Pulmonary resuscitator, manual, single-use
Primary Device IDB0024010U3
NIH Device Record Key32ec46b2-b568-4333-89d1-0a02f4b18729
Commercial Distribution StatusIn Commercial Distribution
Brand NameRescuer Child BVM Manual Rescusitator
Version Model Number4010U
Catalog Number4010U
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

Phone905 339 1069
Emailtedreesor@blssystemsltd.com
Phone905 339 1069
Emailtedreesor@blssystemsltd.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0024010U0 [Primary]
HIBCCB0024010U3 [Package]
Contains: B0024010U0
Package: Case of 12 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-02-13

Devices Manufactured by B.L.S. Systems Limited

B0024050RB7 - Rescuer2024-06-20 Replacement reservoir bag (2.9L) for 4000 series manual resuscitator
B0023000X7 - Rescuer2023-12-19 Rescuer CPR Shield with gloves
B0026200U0 - Rescuer O-Mask2021-04-09 Rescuer O-Mask with Universal Tubing (Large Adult)
B0026205U7 - Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)2021-04-09 Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
B0026210U7 - Rescuer O-Mask Oxygen Mask with Universal Tubing2021-04-09 Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B0024000F0 - Rescuer2021-01-18 HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
00627843557524 - RUSCH2020-01-17 Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and med
00627843557531 - RUSCH2020-01-17 Blue RUSCH branded Adult sized manual resuscitator , oxygen reservoir bag, swivel connector, medication port, PEEP connector and

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