| Primary Device ID | 06942265501646 |
| NIH Device Record Key | e7dcdfe7-b1f0-47bd-90b2-2956a6938e92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Parafleet SC 014PTA Balloon Dilatation Catheter |
| Version Model Number | rev 02 |
| Catalog Number | F14-025040-090 |
| Company DUNS | 421318800 |
| Company Name | BrosMed Medical Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 06942265501646 [Primary] |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-16 |
| Device Publish Date | 2025-05-08 |
| 06942265500182 | rev 02 |
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