| Primary Device ID | 04056839130001 |
| NIH Device Record Key | a93bbad0-99b1-4428-b2b9-bd267434652e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signia Siemens |
| Version Model Number | HA PURE 13 BT 7PX BG |
| Catalog Number | 10938386 |
| Company DUNS | 157412271 |
| Company Name | SIVANTOS, 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056839130001 [Primary] |
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-08 |
| Device Publish Date | 2018-05-08 |
| 04056839130254 | Signia Siemens HA MOTION S 3PX DRD- DGT Hearing Aid |
| 04056839130247 | Signia Siemens HA PURE 13 BT 3PX BG Hearing Aid |
| 04056839130230 | Signia Siemens HA PURE 13 BT 3PX BLK Hearing Aid |
| 04056839130216 | Signia Siemens HA PURE 13 BT 3PX DBR Hearing Aid |
| 04056839130209 | Signia Siemens HA PURE 13 BT 3PX DGT Hearing Aid |
| 04056839130193 | Signia Siemens HA PURE 13 BT 3PX DKC Hearing Aid |
| 04056839130186 | Signia Siemens HA PURE 13 BT 3PX GB Hearing Aid |
| 04056839130179 | Signia Siemens HA PURE 13 BT 3PX GNT Hearing Aid |
| 04056839130162 | Signia Siemens HA PURE 13 BT 3PX GR Hearing Aid |
| 04056839130155 | Signia Siemens HA PURE 13 BT 3PX PRL Hearing Aid |
| 04056839130148 | Signia Siemens HA PURE 13 BT 3PX SB Hearing Aid |
| 04056839130131 | Signia Siemens HA PURE 13 BT 3PX SLV Hearing Aid |
| 04056839130124 | Signia Siemens HA PURE 13 BT 5PX BG Hearing Aid |
| 04056839130117 | Signia Siemens HA PURE 13 BT 5PX BLK Hearing Aid |
| 04056839130094 | Signia Siemens HA PURE 13 BT 5PX DBR Hearing Aid |
| 04056839130087 | Signia Siemens HA PURE 13 BT 5PX DGT Hearing Aid |
| 04056839130070 | Signia Siemens HA PURE 13 BT 5PX DKC Hearing Aid |
| 04056839130063 | Signia Siemens HA PURE 13 BT 5PX GB Hearing Aid |
| 04056839130056 | Signia Siemens HA PURE 13 BT 5PX GNT Hearing Aid |
| 04056839130049 | Signia Siemens HA PURE 13 BT 5PX GR Hearing Aid |
| 04056839130032 | Signia Siemens HA PURE 13 BT 5PX PRL Hearing Aid |
| 04056839130025 | Signia Siemens HA PURE 13 BT 5PX SB Hearing Aid |
| 04056839130018 | Signia Siemens HA PURE 13 BT 5PX SLV Hearing Aid |
| 04056839130001 | Signia Siemens HA PURE 13 BT 7PX BG Hearing Aid |
| 04056839129999 | Signia Siemens HA PURE 13 BT 7PX BLK Hearing Aid |
| 04056839129975 | Signia Siemens HA PURE 13 BT 7PX DBR Hearing Aid |
| 04056839129968 | Signia Siemens HA PURE 13 BT 7PX DGT Hearing Aid |
| 04056839129951 | Signia Siemens HA PURE 13 BT 7PX DKC Hearing Aid |
| 04056839129944 | Signia Siemens HA PURE 13 BT 7PX GB Hearing Aid |
| 04056839129937 | Signia Siemens HA PURE 13 BT 7PX GNT Hearing Aid |
| 04056839129920 | Signia Siemens HA PURE 13 BT 7PX GR Hearing Aid |
| 04056839129913 | Signia Siemens HA PURE 13 BT 7PX PRL Hearing Aid |
| 04056839129906 | Signia Siemens HA PURE 13 BT 7PX SB Hearing Aid |
| 04056839129890 | Signia Siemens HA PURE 13 BT 7PX SLV Hearing Aid |
| 04056839129777 | Signia Siemens INSIO 3PX Hearing Aid |
| 04056839129760 | Signia Siemens INSIO 5PX Hearing Aid |
| 04056839129753 | Signia Siemens INSIO 7PX Hearing Aid |
| 04056839129371 | Signia Siemens HA MOTION SX SDEMO DPX GNT Hearing Aid |
| 04056839128534 | Signia Siemens HA PURE 7PX BG Hearing Aid |
| 04056839128527 | Signia Siemens HA MOTION SA SDEMO DPX GNT Hearing Aid |
| 04056839128305 | Signia Siemens HA MOTION SX 5PX DKC Hearing Aid |
| 04056839126547 | Signia Siemens HA MOTION SA 3PX DRD Hearing Aid |
| 04056839126530 | Signia Siemens HA MOTION SA 5PX DRD Hearing Aid |
| 04056839126523 | Signia Siemens HA MOTION SA 7PX DRD Hearing Aid |
| 04056839126516 | Signia Siemens HA MOTION SX 7PX DRD Hearing Aid |
| 04056839126509 | Signia Siemens HA MOTION SX 5PX DRD Hearing Aid |
| 04056839126493 | Signia Siemens HA MOTION SX 3PX DRD Hearing Aid |
| 04056839126455 | Signia Siemens HA PURE 5PX DRD Hearing Aid |
| 04056839126448 | Signia Siemens HA PURE 7PX DRD Hearing Aid |
| 04056839126431 | Signia Siemens HA PURE 3PX DRD Hearing Aid |