FDA UDI
In Commercial Distribution
🇺🇸 United States
Joseph
DI: 00827002170438
·
Model: G17043
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Joseph
- Primary DI
- 00827002170438
- Version / Model
- G17043
- Catalog Number
- 020607-RM
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2020-08-17
- Public Version Status
- Update
- Public Device Record Key
- 5344b93e-8a43-4873-a4fa-e67c56b6ba8d
Device Description
Joseph Urodynamic Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAP | CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62244 | Urodynamic manometric catheter, non-electronic | A sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002170438 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.