FDA.reportPublic FDA data

"Paediatric Ventimyst Dual Heated Wire B/S 1.6m (63"") Kit 2"

Primary DI
05055788770008
Brand
"Paediatric Ventimyst Dual Heated Wire B/S 1.6m (63"") Kit 2"
Company
FLEXICARE MEDICAL LIMITED
Model
038-32-252U
Published
2018-02-12
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
K160540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160540000FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMFlexicare Medical Limited.2016-06-23BZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788770008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788770008050557887700085055788770008

GMDN Terms#

Term, Definition table
TermDefinition
Carpal lunate prosthesisA sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
Lot or batch
true
Expiration date on label
true

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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

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