| Primary Device ID | 09341394012400 |
| NIH Device Record Key | 027206dc-969d-4ef3-8cc0-e3b739751218 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUREFILL |
| Version Model Number | AKPEI01 |
| Catalog Number | AKPEI01 |
| Company DUNS | 008186174 |
| Company Name | AERO HEALTHCARE (US), LLC |
| 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 | true |
| Device Combination Product | true |
| Single Use | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09341394012400 [Primary] |
| LRR | First Aid Kit With Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-18 |
| Device Publish Date | 2023-12-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUREFILL 90609199 not registered Live/Pending |
Aero Health Aust Pty Ltd 2021-03-29 |
![]() SUREFILL 90609197 not registered Live/Pending |
Aero Health Aust Pty Ltd 2021-03-29 |
![]() SUREFILL 88659651 not registered Live/Pending |
Reliable Packaging Systems Inc 2019-10-18 |
![]() SUREFILL 88388165 5868517 Live/Registered |
SCHOLLE IPN CORPORATION 2019-04-16 |
![]() SUREFILL 87079038 5133050 Live/Registered |
Baker Hughes Incorporated 2016-06-21 |
![]() SUREFILL 77023087 3527991 Live/Registered |
FXI, INC. 2006-10-17 |
![]() SUREFILL 75879430 2464652 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1999-12-22 |
![]() SUREFILL 75262353 not registered Dead/Abandoned |
Safe Alternatives Corporation of America, Inc. 1997-03-21 |
![]() SUREFILL 74705160 2149632 Dead/Cancelled |
HORSTINE FARMERY LIMITED 1995-07-19 |