FDA.reportPublic FDA data

Rescuer Emergency CPAP System

Primary DI
B00287050
Brand
Rescuer Emergency CPAP System
Company
B.L.S. Systems Limited
Model
8705
Catalog number
8705
Device description
Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute episodes of respiratory distress.
Published
2015-05-05
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
K122610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122610000PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.2013-08-05BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00287050PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9053391069tedreesor@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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Primary DI, Brand, Company table
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