Flow-Safe II Disposable CPAP System

Primary DI
10641043572443
Brand
Flow-Safe II Disposable CPAP System
Company
MERCURY ENTERPRISES, INC.
Model
10-57244
Published
2020-11-12
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
K090710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090710000MERCURY CPAPMercury Medical2009-08-20BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30641043572447PackageGS110In Commercial Distribution
10641043572443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3064104357244730641043572447
1064104357244310641043572443

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
(727) 573-0088hospitalcustomerservice@mercurymed.com

Regulatory Flags#

DUNS number
032705659
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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10641043913161Neo-Tee T-Piece Resuscitator CircuitM1091316VSM1091316VS2024-02-08
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