FDA UDI
In Commercial Distribution
🇺🇸 United States
Securmeter Foley Manometer
DI: 08032248471030
·
Model: HM004
·
DELTA MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Securmeter Foley Manometer
- Primary DI
- 08032248471030
- Version / Model
- HM004
- Company Name
- DELTA MED SPA
- Labeler DUNS
- 444776777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-19
- Public Version
- 1
- Public Version Date
- 2025-05-27
- Public Version Status
- New
- Public Device Record Key
- de03cf3b-e50a-4c11-90d6-901b75359d47
Device Description
Inta-abdominal pressure measuring system
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
- Yes
- 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 |
|---|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47505 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38032248471031 | GS1 | case | 20 | In Commercial Distribution | |
| Primary | 08032248471030 | GS1 | ||||
| Package | 58032248471035 | GS1 | shipping box | 24 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 103 | Centimeter | |
| Outer Diameter | 6.8 | Millimeter |