| Primary Device ID | 06971564462976 | 
| NIH Device Record Key | 6b67fc63-ad63-4bbd-a9f9-2920323e4f93 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | GBUK | 
| Version Model Number | 10mL | 
| Catalog Number | PFS-10DSU | 
| Company DUNS | 544543513 | 
| Company Name | Jiangsu Caina 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 | 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 | 06971564462976 [Primary] | 
| GS1 | 16971564462973 [Package] Package: [30 Units] In Commercial Distribution  | 
| GS1 | 26971564462970 [Package] Package: [240 Units] In Commercial Distribution  | 
| NGT | Saline, Vascular Access Flush | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-05-22 | 
| Device Publish Date | 2025-05-14 | 
| 06971564462976 | 10ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9%NaCl),USP | 
| 16971564461136 | 10 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl) | 
| 16971564461129 | 5ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP | 
| 06971564461115 | 3 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP | 
| 06971564461108 | 10 ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9% Na Cl), USP |