| Primary Device ID | 06947358561507 |
| NIH Device Record Key | 87e5b1f0-76c8-4cad-8751-bfd626f932ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunmed Inflation Device |
| Version Model Number | 20ml, 30atm |
| Company DUNS | 529639795 |
| Company Name | Sunny Medical Device (Shenzhen) Co., Ltd. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06947358561507 [Primary] |
| PTM | Syringe, Balloon Inflation, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-09 |
| Device Publish Date | 2021-06-01 |
| 06947358535539 - Sunmed™ guide wires | 2024-01-15 |
| 06947358563402 - Sunmed Inflation devices | 2023-10-03 |
| 06947358546719 - Sunmed Haemostatic Valves | 2023-07-14 |
| 06947358571698 - Sunmed disposable needles | 2023-07-14 |
| 06947358582618 - Sunmed disposable angio-closure pads | 2023-07-14 |
| 06947358544302 - Sunmed guidewire torque device | 2022-01-12 |
| 06947358566007 - Sunmed Inflation Device | 2022-01-12 |
| 06947358568001 - Sunmed Inflation Device | 2022-01-12 |