| Primary Device ID | 04987488091187 |
| NIH Device Record Key | b2ff0cf0-4658-4f36-9e9e-f96c914f0c02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter |
| Version Model Number | PBMA-21G |
| Company DUNS | 690625850 |
| Company Name | SB-KAWASUMI LABORATORIES, INC. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987488091187 [Primary] |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2023-06-28 |
| 04987488091200 | K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti- |
| 04987488091194 | K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti- |
| 04987488091187 | K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti- |