WATER PUMP TUBIG KIT
- Primary DI
- 03700512906223
- Brand
- WATER PUMP TUBIG KIT
- Company
- Promepla
- Model
- ONG03399ST280
- Catalog number
- 84411165-2
- Device description
- Urodynamic testing / Cystomery
- Published
- 2023-01-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FEN | Device, Cystometric, Hydraulic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | Gastroenterology, Urology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03700512916222 | Package | GS1 | 25 | In Commercial Distribution |
| 03700512926221 | Package | GS1 | 200 | In Commercial Distribution |
| 03700512906223 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03700512916222 | 03700512916222 | 3700512916222 |
| 03700512926221 | 03700512926221 | 3700512926221 |
| 03700512906223 | 03700512906223 | 3700512906223 |
GMDN Terms#
| Term | Definition |
|---|---|
| Urological irrigation system | An assembly of devices intended for the infusion of sterile fluids (e.g., saline, water) into the ureter and upper urinary tract to irrigate these passageways in a controlled manner during a diagnostic and /or a therapeutic urological procedure; including a urinary tract endoscopic procedure. It typically consists of a mains electricity (AC-powered) pump, tubing, connectors and other items that enable the pressure, temperature, or flow of water to be controlled. |
Regulatory Flags#
- DUNS number
- 401020409
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03700512905059 | Irrigation Tube | OSG03399E5ST35 | Y900197 | 2024-10-24 |
| 03700512905073 | Irrigation Tube | OSG03499ST35 | C823752 | 2024-10-24 |
| 03700512905196 | Irrigation Tube | ODG05599E5ST35 | Y1500070 | 2024-10-24 |
| 03700512925064 | Irrigation Tube | OSG03399E5ST35 | Y900197 | 2024-10-24 |
| 03700512925071 | Irrigation Tube | OSG03499ST35 | C823752 | 2024-10-24 |
| 03700512915263 | Irrigation Tube | ODG05599E5ST35 | Y1500070 | 2024-10-24 |
| 03700512901969 | Y-CLIC ADAPTER | 09-0197 | ROMYCLICST228 | 2018-08-20 |
| 03700512963592 | BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm | ROUS1235ST | ROUS1235ST | 2016-10-03 |
| 03700512963608 | BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cm | ROUS1045ST | ROUS1045ST | 2016-10-03 |
| 03700512963615 | BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm | ROUS1245ST | ROUS1245ST | 2016-10-03 |
| 03700512965589 | RocaFlex Access Sheath & Dilation Catheter 10/12x35cm | AS101235 | AS101235 | 2016-09-14 |
| 03700512965596 | RocaFlex Access Sheath & Dilation Catheter 12/14x35cm | AS101245 | AS101245 | 2016-09-14 |
| 03700512965602 | RocaFlex Access Sheath & Dilation Catheter 10/12x45cm | AS121435 | AS121435 | 2016-09-14 |
| 03700512965619 | RocaFlex Access Sheath & Dilation Catheter 12/14x45cm | AS121445 | AS121445 | 2016-09-14 |
| 03700512966197 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm | 09-0015 | ROUS1035ST | 2017-11-09 |
| 03700512966203 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm | 09-0016 | ROUS1235ST | 2017-11-09 |
| 03700512966210 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm | 09-0017 | ROUS1045ST | 2017-11-09 |
| 03700512966227 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm | 09-0018 | ROUS1245ST | 2017-11-09 |
| 03700512967453 | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire | 09-0124 | ROJS9522ST228 | 2018-08-20 |
| 03700512967460 | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire | 09-0125 | ROJS9524ST228 | 2018-08-20 |
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| 10627825010358 | Tubing, Extension Line, Clear, with Stopcock, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
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| 10627825010372 | Tubing, Extension Line, Blue for Pves, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010389 | Tubing, Extension Line, Red for Pabd, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010396 | Tubing, Extension Line, Yellow for Pura, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010402 | Tubing, Extension Line, 2 Set, Blue/Red, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010419 | Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010426 | Pump Guard / Dampening chamber | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010440 | Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 12Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010457 | Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 9Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
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| 10627825010488 | Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
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