FDA.report

Goby

Primary DI
00627825003575
Brand
Goby
Company
Laborie Medical Technologies Canada ULC
Model
GBS007
Device description
Urodynamic Analyzer System with Medical Grade Power Supply, NGM Version
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FENDEVICE, CYSTOMETRIC, HYDRAULIC

Product Code Classifications

CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00627825003575PrimaryGS10

GMDN Terms

TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

Sterilization Methods

Method

Regulatory Flags

DUNS number
203383526
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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20627825007324Extension Line, 15cm9021P63512016-09-21
20627825007348Extension Line, 150cm Blue9021P63712016-09-21
30627825007352Extension Line, 150cm Yellow9021P63812016-09-21
20627825007034Extension Set 39021P12932016-09-21
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20627825010355Tubing, Extension Line, Clear, with Stopcock, 150 cmTUBEX1CS2017-10-01
20627825010362Tubing, Extension Line, Clear, 150 cmTUBEX1C2017-10-01
20627825010379Tubing, Extension Line, Blue for Pves, 150 cmTUBEX1B2017-10-01
20627825010386Tubing, Extension Line, Red for Pabd, 150 cmTUBEX1R2017-10-01
30627825010390Tubing, Extension Line, Yellow for Pura, 150 cmTUBEX1Y2017-10-01
30627825010406Tubing, Extension Line, 2 Set, Blue/Red, 150 cmTUBEX2BR2017-10-01
20627825010416Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cmTUBEX3BRY2017-10-01
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