FDA.reportPublic FDA data

FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit

Primary DI
00709078004414
Brand
FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit
Company
WESTMED, INC.
Model
9571
Published
2017-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)
OGLOxygen Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1
OGLOxygen Administration KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922492000SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERSpecialty Packaging Producs, Inc.1992-08-24CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078004411PackageGS110Not in Commercial Distribution
00709078004414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800441110709078004411
00709078004414007090780044147090780044140709078004414

GMDN Terms#

Term, Definition table
TermDefinition
Stationary angiographic x-ray system, analogueA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses analogue or analogue-to-digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.

Regulatory Flags#

DUNS number
092673953
Device count
1
Kit
true
Lot or batch
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
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00709078013041CapetteCP-44032021-06-25
00709078013058StrapetteCP-42042021-06-25
00709078013065StrapetteCP-42202021-06-25
00709078013072StrapetteCP-44042021-06-25
00709078013089StrapetteCP-44202021-06-25
00709078013096ChinstrapCP-51002021-06-25
00709078013102ChinstrapCP-52002021-06-25
00709078013119Septal-HCP-54002021-06-30
00709078013126Septal-HCP-54102021-06-30
00709078013133Septal-HCP-55002021-06-30
00709078013140Septal-HCP-55102021-06-30
00709078013157SavEarRT-61002021-06-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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