FDA.reportPublic FDA data

Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit

Primary DI
00709078005466
Brand
Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
Company
WESTMED, INC.
Model
A9242
Published
2018-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904538000MAUNA LOA ENHANCED HEATED BREATHING CIRCUITMauna Loa Medical, Inc.1991-04-24CAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078005463PackageGS110In Commercial Distribution
00709078005466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800546310709078005463
00709078005466007090780054667090780054660709078005466

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopy carbon dioxide gas/refillable cylinderCompressed medical carbon dioxide (CO2) in a dedicated refillable container intended to be used for laparoscopic insufflation. The cylinder is filled with CO2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and is graded according to size (capacity) and colour-coded to denote CO2 content. It is typically made of steel and must be used together with a pressure regulator in order to release the CO2 at the correct working pressure.

Regulatory Flags#

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

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00709078013003CapetteCP-42022021-06-25
00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
00709078013034CapetteCP-44022021-06-25
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
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10197344043040HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
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