| Primary Device ID | 38032248471031 |
| NIH Device Record Key | de03cf3b-e50a-4c11-90d6-901b75359d47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Securmeter Foley Manometer |
| Version Model Number | HM004 |
| Company DUNS | 444776777 |
| Company Name | DELTA MED SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Length | 103 Centimeter |
| Outer Diameter | 6.8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08032248471030 [Primary] |
| GS1 | 38032248471031 [Package] Contains: 08032248471030 Package: case [20 Units] In Commercial Distribution |
| GS1 | 58032248471035 [Package] Package: shipping box [24 Units] In Commercial Distribution |
| FEN | Device, Cystometric, Hydraulic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-27 |
| Device Publish Date | 2025-05-19 |
| 38032248487124 - Atmos | 2025-09-10 Pump Tubing 4x6 mm |
| 08032248487130 - Atmos | 2025-09-10 Pump Tubing 3,2 x 6,4 |
| 38032248487148 - Atmos | 2025-09-10 Pump Tubing 5x8mm |
| 38032248487186 - Infusion Set | 2025-09-10 Pump Tubing 4x6mm |
| 38032248490131 - Atmos | 2025-09-10 Transparent Extension Line 1500mm |
| 38032248471031 - Securmeter Foley Manometer | 2025-05-27Inta-abdominal pressure measuring system |
| 38032248471031 - Securmeter Foley Manometer | 2025-05-27 Inta-abdominal pressure measuring system |
| 38032248007124 - SOL CARE T | 2021-04-07 I.V. Catheter with protector |
| 38032248007131 - SOL CARE T | 2021-04-07 I.V. Catheter with protector |