Rescuer

Primary DI
B0024000F0
Brand
Rescuer
Company
B.L.S. Systems Limited
Model
4000F
Catalog number
4000F
Device description
HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
Published
2021-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993194000RUSCH MANUAL RESUSCITATOR BAGRusch, Inc.2000-03-24BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0024000F2PackageHIBCC10In Commercial Distribution
B0024000F3PackageHIBCC12In Commercial Distribution
B0024000F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
19053391069tedreesor@blssystemsltd.com

Regulatory Flags#

DUNS number
200103823
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B0028705NK0Rescuer Emergency CPAP with Medium CPAP Mask8705-NK8705-NK2020-01-06
B0024000UF0Rescuer Manual Resuscitator4000-U-F4000-U-F2021-04-20
B0024010UF0Rescuer Manual Resuscitator4010-U-F4010-U-F2021-04-20
B0024025UF0Rescuer Manual Resuscitator 4025-U-F4025-U-F2021-04-20
B0024050UF0Rescuer Manual Resuscitator4050-U-F4050-U-F2021-04-20
B0026205U0Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)6205-U6205-U2021-04-01
B0026210U0Rescuer O-Mask Oxygen Mask with Universal Tubing6210-U6210-U2021-04-01
B0026200U0Rescuer O-Mask6200-U6200-U2021-04-01
B0026205U7Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)6205-U6205-U2021-04-01
B0026210U7Rescuer O-Mask Oxygen Mask with Universal Tubing6210-U6210-U2021-04-01
B0026100U0Rescuer Flo2Max Oxygen Mask, Large Adult61006100-U2020-11-12
B0026105U0Rescuer Flo2Max Oxygen Mask, Small Adult6105-U6105-U2020-11-12

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