FDA.reportPublic FDA data

Adult Circ Sing Lmb HTD/W (22mm Shielded Tube) & AutoFCh

Primary DI
05055788709664
Brand
Adult Circ Sing Lmb HTD/W (22mm Shielded Tube) & AutoFCh
Company
FLEXICARE MEDICAL LIMITED
Model
038-35-963U
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150900000Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.2015-05-15BZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788709664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788709664050557887096645055788709664

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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Primary DI, Brand, Model table
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05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
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05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

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