FDA.report

inspired™

Primary DI
64896138001006
Brand
inspired™
Company
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Model
2096536-004
Device description
PATIENT CIRCUIT STARTUP KIT ADULT, DISPOSABLE
Published
2020-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
64896138001006PackageGS110In Commercial Distribution
14896138001001PrimaryGS10

GMDN Terms

TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
663901361
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
64896138000863inspired™2096533-0012020-09-18
64896138000870inspired™2096533-0022020-09-18
14896138000882inspired™2096533-0032020-09-18
64896138000894inspired™2096533-0042020-09-18
64896138000900inspired™2096534-0012020-09-18
64896138000917inspired™2096534-0022020-09-18
64896138000924inspired™2096534-0052020-09-18
64896138000931inspired™2096534-0062020-09-18
64896138000948inspired™2096534-0072020-09-18
64896138000955inspired™2096534-0082020-09-18
64896138000962inspired™2096534-0092020-09-18
64896138000979inspired™2096535-0012020-09-18
64896138000993inspired™2096536-0032020-09-18
64896138001013inspired™2096534-1032020-09-18
64896138001020inspired™2096536-0012020-09-18
64896138001037inspired™2096536-0022020-09-18
64896138001044inspired™2096534-0032020-09-18
64896138001051inspired™2096534-0042020-09-18
64896138001068inspired™2096534-1042020-09-18
64896138001075inspired™2096535-0022020-09-18

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