AED PLUS AED+ S SCH
GUDID B800AEDSSCH5
AED PLUS
UTAK LABORATORIES, INC.
Multiple-type clinical chemistry analyte profile IVD, control| Primary Device ID | B800AEDSSCH5 |
| NIH Device Record Key | ec72c626-2080-4ba0-871d-4f5a69982529 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AED PLUS |
| Version Model Number | AED+ S SCH |
| Catalog Number | AED+ S SCH |
| Company DUNS | 092519016 |
| Company Name | UTAK LABORATORIES, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM | |
| Phone | 8888825522 |
| WELOVECONTROL@UTAK.COM |
Device Dimensions
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800AEDSSCH0 [Primary] |
| HIBCC | B800AEDSSCH5 [Package] Contains: B800AEDSSCH0 Package: box [10 Units] In Commercial Distribution |
FDA Product Code
| LAS | Drug Specific Control Materials |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-25 |
| Device Publish Date | 2024-07-17 |
Devices Manufactured by UTAK LABORATORIES, INC.
| B800AEDSSCH5 - AED PLUS | 2024-07-25AED PLUS |
| B800AEDSSCH5 - AED PLUS | 2024-07-25 AED PLUS |
| B800METH1UCD5 - METHANOL PLUS 1 | 2024-07-25 METHANOL PLUS 1 |
| B800METH2UCD5 - METHANOL PLUS 2 | 2024-07-25 METHANOL PLUS 2 |
| B800TESTO1SFMC5 - TESTOSTERONE LEVEL 1 | 2024-07-25 TESTOSTERONE LEVEL 1 |
| B800TESTO2SFMC5 - TESTOSTERONE LEVEL 2 | 2024-07-25 TESTOSTERONE LEVEL 2 |
| B800TESTO3SFMC5 - TESTOSTERONE LEVEL 3 | 2024-07-25 TESTOSTERONE LEVEL 3 |
| B800BUP2V2UKP5 - BUPRENORPHINE PLUS LEVEL 2 V2 | 2024-07-22 BUPRENORPHINE PLUS LEVEL 2 V2 |
| B800NICO100V3UFUWHC5 - NICOTINE PLUS 100 NG/ML V3 | 2024-07-11 NICOTINE PLUS 100 NG/ML V3 |
Trademark Results [AED PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AED PLUS 78709147 3183157 Live/Registered |
Zoll Medical Corporation 2005-09-08 |
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