FDA.reportPublic FDA data

Oxygen Concentrator

Primary DI
05060488571671
Brand
Oxygen Concentrator
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
PMCON5L
Catalog number
PMCON5L
Device description
Oxygen Concentrator, 5 Litre
Published
2021-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090007000JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd.2009-07-24CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488571671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488571671050604885716715060488571671

GMDN Terms#

Term, Definition table
TermDefinition
Stationary oxygen concentratorA stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height22Inch
Length11Inch
Width13Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags#

DUNS number
078582655
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05060488573316Protekt PartsPP-AHFAASMK3LFTPP-AHFAASMK3LFT2022-11-18
05060488573323Protekt PartsPP-AHFAASMK3RTPP-AHFAASMK3RT2022-11-18
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05060488570186Protekt Aire94004940042016-08-12
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05060488570551Protekt Aire Replacement Mattress80087800872016-08-12
05060488570728Protekt Aire83500835002018-03-07
05060488570735Protekt Aire83600836002018-03-07
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Primary DI, Brand, Company table
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