Southeastern
GUDID 04719871890653
CPR Resuscitator Adult/Child
FOREMOUNT ENTERPRISE CO., LTD.
Resuscitator face mask, single-use| Primary Device ID | 04719871890653 |
| NIH Device Record Key | d31bb80f-6eca-464e-bc9b-c4594f28dcf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Southeastern |
| Version Model Number | ME6201-SEE |
| Company DUNS | 658718465 |
| Company Name | FOREMOUNT ENTERPRISE CO., LTD. |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719871890653 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042727
FDA Product Code
| CBP | Valve, Non-Rebreathing |
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 | 2024-07-08 |
| Device Publish Date | 2024-06-28 |
Devices Manufactured by FOREMOUNT ENTERPRISE CO., LTD.
| 04719871892251 - JBC | 2024-07-26 Heat And Moisture Exchange Filters (HMEF) |
| 04719871890011 - WNL | 2024-07-08 CPR Resuscitator in red hard case Adult/Child Infant |
| 04719871890028 - WNL | 2024-07-08 CPR Mask in Red Soft Case Adult/Child Infant with mask |
| 04719871890042 - WNL | 2024-07-08 CPR Mask in Red Soft Case Adult/Child Infant |
| 04719871890059 - WNL | 2024-07-08 CPR Resuscitator in red hard case Adult/Child Infant with mask |
| 04719871890066 - ARC | 2024-07-08 CPR Mask in Red Soft Case Adult/Child Infant |
| 04719871890073 - WNL | 2024-07-08 Replacement Valve for CPR Mask |
| 04719871890080 - Fukuoka | 2024-07-08 CPR Mask in Blue Soft Case Adult/Child Infant |
Trademark Results [Southeastern]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOUTHEASTERN 98280307 not registered Live/Pending |
Sim-Abb, LLC 2023-11-21 |
 SOUTHEASTERN 97220314 not registered Live/Pending |
Fulcrum Building Group, LLC 2022-01-14 |
 SOUTHEASTERN 87858116 not registered Dead/Abandoned |
Shim, Jae W 2018-03-31 |
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