| Primary Device ID | 04038917983280 | 
| NIH Device Record Key | cde1759b-5769-4760-b268-34fe20e18a56 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | S-Monovette® 1.6ml Serum CAT | 
| Version Model Number | 04.2911.001 | 
| Catalog Number | 04.2911.001 | 
| Company DUNS | 388000270 | 
| Company Name | Sarstedt Aktiengesellschaft & Co.KG | 
| Device Count | 50 | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | |
| Phone | +1(800)257-5101 | 
| customerservice.us@sarstedt.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04038917983280 [Unit of Use] | 
| GS1 | 04038917983297 [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 | 2025-10-03 | 
| Device Publish Date | 2025-09-25 | 
| 04038917983310 | 04.2911.200 | 
| 04038917983280 | 04.2911.001 | 
| 04038917983259 | 04.2911 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  S-MONOVETTE  79035683  3405724 Live/Registered | SARSTEDT AG & Co. KG 2006-12-08 |