FDA.report

LTV

Primary DI
00845873002634
Brand
LTV
Company
Carefusion Corporation
Model
18888-005
Device description
ASSY, LTV1200, W/ ACCESS, ITALIAN
Published
2015-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845873002634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845873002634008458730026348458730026340845873002634

GMDN Terms

TermDefinition
Transport electric ventilatorAn electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

Sterilization Methods

Method

Regulatory Flags

DUNS number
830432451
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10190752101913TiaraTMS-2831912016-09-13
10190752101920TiaraTMS-2840912016-09-13
10190752101944TiaraTMS-2841912016-09-13
10190752101951TiaraTMS-2850912016-09-13
10190752101975TiaraTMS-2851912016-09-13
10190752102033TiaraTMS-12032016-09-13
10190752102040TiaraTMS-1203782016-09-13
10190752102057TiaraTMS-12532016-09-13
10190752102064TiaraTMS-1253782016-09-13
10190752102071TiaraTMS-14032016-09-13
10190752102088TiaraTMS-1403782016-09-13
10190752102095TiaraTMS-25202016-09-13
10190752102101TiaraTMS-25402016-09-13
10190752102118TiaraTMS-2540782016-09-13
10190752102125TiaraTMS-28202016-09-13
10190752102132TiaraTMS-28302016-09-13
10190752102149TiaraTMS-28402016-09-13

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