KIEFER
GUDID 04719871891582
RISE Infant Pocket Mask in PE Bag
FOREMOUNT ENTERPRISE CO., LTD.
Resuscitator face mask, single-use| Primary Device ID | 04719871891582 |
| NIH Device Record Key | aa0fda0d-6ad2-459a-b4cd-18ff860261e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIEFER |
| Version Model Number | ME6161Z |
| 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 | 04719871891582 [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 [KIEFER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KIEFER 85525332 4260413 Live/Registered |
Adolph Kiefer & Associates, LLC 2012-01-25 |
 KIEFER 85299832 4162230 Dead/Cancelled |
KIEFER MFG AND SALES, LLC 2011-04-20 |
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