Securmeter Foley Manometer
- Primary DI
- 38032248471031
- Brand
- Securmeter Foley Manometer
- Company
- DELTA MED SPA
- Model
- HM004
- Device description
- Inta-abdominal pressure measuring system
- Published
- 2025-05-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- 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 |
|---|---|---|---|---|
| 38032248471031 | Package | GS1 | 20 | In Commercial Distribution |
| 58032248471035 | Package | GS1 | 24 | In Commercial Distribution |
| 08032248471030 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 38032248471031 | 38032248471031 | |
| 58032248471035 | 58032248471035 | |
| 08032248471030 | 08032248471030 | 8032248471030 |
GMDN Terms#
| Term | Definition |
|---|---|
| Intra-abdominal pressure measurement set, mechanical | A collection of devices designed to measure intra-abdominal pressure (IAP) through the bladder. It typically includes a tube with graduated markings in mm Hg (manometer tube), clamps, a filter, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), and IAP is measured by the manometer tube based on urine level in the tube. It is typically used to measure IAP in patients at risk of intra-abdominal hypertension (IAH) such as following abdominal surgery, abdominal trauma, ventilated patients with organ dysfunction, and patients suspected of abdominal compartment syndrome (ACS). This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 103 | Centimeter |
| Outer Diameter | 6.8 | Millimeter |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 444776777
- 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 DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08032248487123 | Atmos | UD-46215 | 2025-09-02 | |
| 08032248487147 | Atmos | UD-A58245 | 2025-09-02 | |
| 08032248487185 | Infusion Set | MMT1173 | 2025-09-02 | |
| 08032248490130 | Atmos | UD-AELN | 2025-09-02 | |
| 38032248487124 | Atmos | UD-46215 | 2025-09-02 | |
| 08032248487130 | Atmos | UD-A36205 | 2025-09-02 | |
| 38032248487148 | Atmos | UD-A58245 | 2025-09-02 | |
| 38032248487186 | Infusion Set | MMT1173 | 2025-09-02 | |
| 38032248490131 | Atmos | UD-AELN | 2025-09-02 | |
| 08032248471030 | Securmeter Foley Manometer | HM004 | 2025-05-19 | |
| 08032248127401 | NA | 12T7400 | 2016-09-23 | |
| 08032248007123 | SOL CARE T | SIV001 | 2021-03-30 | |
| 08032248007130 | SOL CARE T | SIV002 | 2021-03-30 | |
| 08032248007147 | SOL CARE T | SIV003 | 2021-03-30 | |
| 08032248007154 | SOL CARE T | SIV004 | 2021-03-30 | |
| 08032248007161 | SOL CARE T | SIV005 | 2021-03-30 | |
| 08032248007178 | SOL CARE T | SIV006 | 2021-03-30 | |
| 08032248007185 | SOL CARE T | SIV007 | 2021-03-30 | |
| 08032248007192 | SOL CARE T | SIV008 | 2021-03-30 | |
| 08032248007208 | SOL CARE T | SIV009 | 2021-03-30 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 08032248471030 | Securmeter Foley Manometer | DELTA MED SPA | FEN | 2025-05-19 |
| 10627825014844 | T-DOC 5Fr Air-Charged Abdominal Sensor Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 10627825014851 | T-DOC 5Fr Air-Charged Single Sensor Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 10627825014868 | T-DOC 5Fr Air-Charged Single Sensor Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 00627825000574 | 2-Way Stop Cock | Laborie Medical Technologies Canada ULC | FEN | 2020-10-02 |
| 00627825000581 | 4-Way Stop Cock | Laborie Medical Technologies Canada ULC | FEN | 2020-10-02 |
| 10627825010433 | Catheter, Pabd, Dual Lumen, Closed Balloon, Latex, 12Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-11-01 |
| 10627825010273 | Tubing, Infusion Pump for Laborie Systems | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010280 | Tubing, Infusion Pump for MMS Solar Systems | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010297 | Tubing, Infusion Pump for MMS Solar Systems, with spikes | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010303 | Tubing, Infusion Pump for MMS Solar Systems, with chamber | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010310 | Tubing, Infusion Pump for MMS Nexam NPU Systems | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010327 | Tubing, Infusion Pump for Andromeda Systems | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010334 | Tubing, Infusion Pump for Mediwatch Systems | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010358 | Tubing, Extension Line, Clear, with Stopcock, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010365 | Tubing, Extension Line, Clear, 150 cm | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 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 |
| 10627825010464 | Catheter, Pabd, Single Lumen, Closed Balloon, Latex, 12Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010471 | Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010488 | Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010495 | Catheter, Pabd, Single Lumen, Split Balloon, PVC, 4.5Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010501 | Catheter, Pves & Vinf, Dual Lumen, 6Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |
| 10627825010518 | Catheter, Pves & Vinf, Dual Lumen, 8Fr | Laborie Medical Technologies Canada ULC | FEN | 2017-10-01 |