FDA UDI
In Commercial Distribution
🇺🇸 United States
Goby
DI: 00627825003575
·
Model: GBS007
·
Laborie Medical Technologies Canada ULC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Goby
- Primary DI
- 00627825003575
- Version / Model
- GBS007
- Company Name
- Laborie Medical Technologies Canada ULC
- Labeler DUNS
- 203383526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d98aa620-2be6-4790-b54e-4a45671a6f70
Device Description
Urodynamic Analyzer System with Medical Grade Power Supply, NGM Version
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14307 | Urodynamic measurement system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00627825003575 | GS1 |