AMSafe® Pre-Filled Normal Saline Flush Syringe IVF1205SS
GUDID 10704411009986
AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Field Ready Preservative Free
AMSINO INTERNATIONAL, INC.
Vascular catheter flush syringe| Primary Device ID | 10704411009986 |
| NIH Device Record Key | 60b0f96d-e852-4c0a-8aec-748a6bfbf94f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMSafe® Pre-Filled Normal Saline Flush Syringe |
| Version Model Number | 1 |
| Catalog Number | IVF1205SS |
| Company DUNS | 825673239 |
| Company Name | AMSINO INTERNATIONAL, INC. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00704411009989 [Primary] |
| GS1 | 10704411009986 [Package] Contains: 00704411009989 Package: Pouch [1 Units] In Commercial Distribution |
| GS1 | 30704411009980 [Package] Package: Box [30 Units] In Commercial Distribution |
| GS1 | 40704411009987 [Package] Contains: 30704411009980 Package: Case [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183473
FDA Product Code
| NGT | Saline, Vascular Access Flush |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-18 |
| Device Publish Date | 2020-02-10 |
On-Brand Devices [AMSafe® Pre-Filled Normal Saline Flush Syringe]
| 10704411010005 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel |
| 10704411009993 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel |
| 10704411009986 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel |
| 10704411009979 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel |
| 30704411009966 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Flui |
| 30704411009959 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Flui |
| 00704411009941 | AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Flui |
| 00704411009934 | 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field |
Trademark Results [AMSafe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMSAFE 85590155 4664115 Live/Registered |
Gateway Safety, Inc. 2012-04-05 |
 AMSAFE 85013236 3919170 Dead/Cancelled |
Amsino International, Inc. 2010-04-13 |
 AMSAFE 78167951 2736886 Dead/Cancelled |
Amsino International, Inc. 2002-09-25 |
 AMSAFE 77579037 3618970 Dead/Cancelled |
AmSafe, Inc. 2008-09-25 |
 AMSAFE 76560865 3074001 Dead/Cancelled |
AGRIUM ADVANCED TECHNOLOGIES (U.S.) INC. 2003-11-19 |
 AMSAFE 76347301 2798629 Live/Registered |
Am-Safe, Incorporated 2001-12-07 |
 AMSAFE 76346091 2740758 Live/Registered |
Am-Safe, Incorporated 2001-12-06 |
 AMSAFE 73282345 1189193 Dead/Cancelled |
Amsafe Security Systems, Inc. 1980-10-20 |
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