S-Monovette® 01.1624.001
GUDID 04038917228299
S-Monovette® 8.8 ml ACD-A
SARSTEDT, INC.
Evacuated blood collection tube IVD, acid citrate dextrose A (ACD-A)| Primary Device ID | 04038917228299 |
| NIH Device Record Key | df29c612-448d-4bb4-90ba-383e3f1bcea9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S-Monovette® |
| Version Model Number | 01.1624.001 |
| Catalog Number | 01.1624.001 |
| Company DUNS | 035410179 |
| Company Name | SARSTEDT, INC. |
| Device Count | 50 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04038917228299 [Package] Contains: 04038917228305 Package: [500 Units] In Commercial Distribution |
| GS1 | 04038917228305 [Primary] |
| GS1 | 04038917228312 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- BK070029
FDA Product Code
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-04-01 |
| Device Publish Date | 2016-09-22 |
Devices Manufactured by SARSTEDT, INC.
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| 04038917554640 - Screw Cap Tube 101x16 RBS with saline | 2022-12-12 Screw Cap Tube 101x16 mm round bottom with skirt with saline |
| 04038917554688 - Screw Cap Tube 82x13 FB with saline | 2022-12-12 Screw Cap Tube 82x13 flat bottom with saline |
| 04038917952552 - Screw Cap Tube 79x16 RB with saline | 2022-12-12 Screw Cap Tube 79x16 mm round bottom with saline |
| 04038917112949 - Screw Cap Tube 120x17 mm, 15 ml, PS | 2022-11-30 Screw Cap Tube 120x17 mm, 15 ml, rack packed, graduations and writing block, polystyrene |
| 04038917112987 - Screw Cap Tube 120x17 mm, 15 ml, PS | 2022-11-30 Screw Cap Tube 120x17 mm, 15 ml, bulk packed, graduations and writing block, polystyrene |
| 04038917113144 - Screw Cap Tube 120x17 mm, 15 ml, PP | 2022-11-30 Screw Cap Tube 120x17 mm, 15 ml, bulk pack, graduations and writing block, polypropylene |
| 04038917104494 - Urine Monovette®, 10ML with luerlock | 2022-11-30 Urine Monovette®, 10ML with luerlock adapter assembled |
Trademark Results [S-Monovette]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 S-MONOVETTE 79035683 3405724 Live/Registered |
SARSTEDT AG & Co. KG 2006-12-08 |
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