FDA.report

inspired™

Primary DI
14896138001117
Brand
inspired™
Company
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Model
2096534-102
Device description
PATIENT TUBE,ADULT,REUSABLE,SILICONE,1.5m
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
false

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
04896138011669Direct MarkingGS10
64896138001112PackageGS125In Commercial Distribution
14896138001117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04896138011669048961380116694896138011669
6489613800111264896138001112
1489613800111714896138001117

GMDN Terms

TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

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
14896138000899inspired™2096533-0042020-09-18
14896138000905inspired™2096534-0012020-09-18
14896138000912inspired™2096534-0022020-09-18
14896138000929inspired™2096534-0052020-09-18
14896138000936inspired™2096534-0062020-09-18
14896138000943inspired™2096534-0072020-09-18
14896138000950inspired™2096534-0082020-09-18
14896138000967inspired™2096534-0092020-09-18
14896138001018inspired™2096534-1032020-09-18
14896138001025inspired™2096536-0012020-09-18
14896138001049inspired™2096534-0032020-09-18
14896138001056inspired™2096534-0042020-09-18
14896138001063inspired™2096534-1042020-09-18
14896138001100inspired™2096534-1012020-09-18
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

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