FDA.reportPublic FDA data

Disposable PEEP Valve

Primary DI
B0024000PEEP0
Brand
Disposable PEEP Valve
Company
B.L.S. Systems Limited
Model
4000-PEEP
Catalog number
4000-PEEP
Device description
Disposable PEEP valve for use on the Rescuer manual resuscitator.
Published
2017-02-13
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
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9814150000-20 CM H20 PEEP VALVECheen Houng Ent. Co. , Ltd.1998-07-14BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0024000PEEP2PackageHIBCC10In Commercial Distribution
B0024000PEEP3PackageHIBCC12In Commercial Distribution
B0024000PEEP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
905 339 1069tedreesor@blssystemsltd.com

Regulatory Flags#

DUNS number
200103823
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0026300Rescuer63002025-11-24
B00263050Rescuer630563052025-11-24
B0024050RB0Rescuer4050-RB4050-RB2024-06-12
B0024050RB7Rescuer4050-RB4050-RB2024-06-12
B0024000F0Rescuer4000F4000F2021-01-08
B0027000AD0Rescuer 7000-AD Replacement Suction Canister kit7000-AD7000-AD2018-10-02
B0027000MVP0Rescuer MVP Manual Vacuum Pump7000-MVP7000-MVP2018-10-02
B0023000X0Rescuer3000-X3000-X2023-12-11
B0023000X7Rescuer3000-X3000-X2023-12-11
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

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