| Primary Device ID | 48859299198116 |
| NIH Device Record Key | f88b2cdf-3821-46b1-a09a-08f5fdea54c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTeZ Pump KVO |
| Version Model Number | 498111 |
| Company DUNS | 662213220 |
| Company Name | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 28859299198112 [Primary] |
| GS1 | 48859299198116 [Package] Contains: 28859299198112 Package: Carton [12 Units] In Commercial Distribution |
| MEB | Pump, Infusion, Elastomeric |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-19 |
| Device Publish Date | 2025-09-11 |
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