| Primary Device ID | 10607411971362 |
| NIH Device Record Key | 5041bc71-55cb-4b04-913c-8ba7fe04302f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CapnuVue |
| Version Model Number | 4737TG-14-0 |
| Catalog Number | 4737TG-14-0 |
| Company DUNS | 022721133 |
| Company Name | SALTER LABS |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *-20 C to 50 C |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607411971365 [Primary] |
| GS1 | 10607411971362 [Package] Contains: 00607411971365 Package: [50 Units] In Commercial Distribution |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-04 |
| Device Publish Date | 2020-01-27 |
| 10607411971416 | CapnoVue Scope O2/CO2 Mask with Luer style connector |
| 10607411971409 | CapnoVue Scope O2/CO2 Mask with Luer style connector |
| 10607411971379 | CapnoVue M1 Mask (Pedatric). Single patient use. |
| 10607411971362 | CapnoVue M1 Mask (Adult). Single patient use. |
| 10607411971355 | CapnoVue M1 Mask (Adult). With thread grip. Single patient use. |
| 10607411971348 | CapnoVue M1 Mask (Adult). Single patient use. |
| 10607411971331 | CapnoVue M1 Mask (Adult). Single patient use. |
| 10607411971324 | CapnoVue M1 Mask (Infant). Single patient use. |
| 10607411971317 | CapnoVue M1 Mask (Pediatric). Single patient use. |
| 10607411971300 | CapnoVue M1 Mask (Adult) with thread grip. Single patient use. |
| 10607411971294 | CapnoVue M1 Mask (Adult) with thread grip. Single patient use. |
| 10607411971287 | CapnoVue M1 Mask (Adult). Single patient use. |
| 10607411971270 | CapnoVue M1 Mask (Adult). Single patient use. |