FDA.reportPublic FDA data

Anapod Breathing Circuit

Primary DI
00709078008887
Brand
Anapod Breathing Circuit
Company
WESTMED, INC.
Model
A9243
Device description
"Anapod Humi-Therm Heated and Humidified Wick Breathing Circuit, 48"" Heated Humidified Transport Circuit, 48"" Expiratory Limb"
Published
2020-07-31
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
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
10709078008884PackageGS110Not in Commercial Distribution
00709078008887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800888410709078008884
00709078008887007090780088877090780088870709078008887

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory gas heating wire, adultA non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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00709078011900A-Line3300-262020-09-30
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00709078013287Atellica® VTR Syringes115613402022-02-28
00709078013300Atellica® VTR Syringes115613412022-02-28
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00709078013348Atellica® VTR Syringes115613432022-02-28
00709078013362Atellica® VTR Syringes115613442022-02-28
00709078013386Atellica® VTR Syringes115613452022-02-28
00709078013409Atellica® VTR Syringes115613462022-02-28

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