FDA.reportPublic FDA data

Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit

Primary DI
B0028805NK0
Brand
Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit
Company
B.L.S. Systems Limited
Model
8805-NK
Catalog number
8805-NK
Device description
Rescuer II Compact CPAP with Medium Deluxe CPAP Mask and Nebulizer Kit
Published
2018-10-02
Public version status
New
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
B0028805NK1PackageHIBCC6In Commercial Distribution
B0028805NK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
In-line CPAP set, nebulizingA portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a face mask, a nebulizer, and may include additional components (e.g., manometer, flowmeter, tubing, mask strap). This is a reusable device once the consumable products have been replenished.

Device Sizes#

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

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
9053361069tedreesor@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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