| Primary Device ID | 30607411400316 |
| NIH Device Record Key | 1ad7983f-b6ea-4436-b8a2-a97197190ae0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 4507-7 |
| Catalog Number | 4507-7 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | |
| 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 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607411400315 [Primary] |
| GS1 | 10607411400312 [Package] Contains: 00607411400315 Package: [10 Units] In Commercial Distribution |
| GS1 | 20607411400319 [Package] Contains: 10607411400312 Package: [25 Units] In Commercial Distribution |
| GS1 | 30607411400316 [Package] Contains: 20607411400319 Package: [200 Units] In Commercial Distribution |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00604711102178 | Infant nasal cannula headset sub assembly. Disposable, single patient use. Obsolete--subassembly |
| 10607411801126 | Adult Nasal High Performance Sensor Cannula 7 1/4" Connect Tubing P/N: 29-4401 Disposable Single |
| 00607499991255 | Pocket Peak - standard range. 1230-0 part number taken out of commercial distribution Correct |
| 10607411981958 | Nocturnal Patient Kit |
| 10607411963053 | Adult. ETCO2 Filtered Nasal Sampling Cannula |
| 10607411963008 | ETCO2 Filtered Sampling Line with adult/pediatric 15 mm airway adapter. With Nafion moisture red |
| 10607411962995 | Infant. ETCO2 Filtered Nasal Sampling Cannula |
| 10607411961370 | Adult. EtCO2/O2 Nasal Divided Cannula, female thread grip O2 connector and male luer style CO2 |
| 10607411961325 | Adult. ETCO2 Filtered Nasal Sampling Cannula |
| 10607411961295 | ETCO2 Filtered Sampling Line, 13'. With Nafion moisture reduction technology. |
| 10607411961288 | ETCO2 Filtered Sampling Line, 6'. With Nafion moisture reduction technology. |
| 10607411961127 | ETCO2 Filtered Sampling Line, 13' length |
| 10607411961110 | ETCO2 Filtered Sampling Line, 6' length |
| 10607411961080 | NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Double Tube |
| 10607411961066 | VitalCheck Blood pressure cuff, reusable, small adult (20.5 - 28.5 cm) Double tube |
| 10607411961059 | Nasal Cannula (adult) Salter Style with 7’ (2.1 m) supply tube |
| 10607411961042 | Nasal Cannula (adult) Salter Style with 4’ (1.2 m) supply tube |
| 10607411961035 | Oxygen Tubing with 1 standard connector (6 mm) and 1 male thread grip connector |
| 10607411961028 | Oxygen Tubing with 1 standard connector (6 mm) and 1 male thread grip connector |
| 10607411961011 | Oxygen Tubing with 2 standard connectors (6 mm) 25' (7.6 m) |
| 10607411959650 | DuraCheck Blood pressure cuff, reusable, adult (16-28 CM), single tube |
| 10607411959629 | StatCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - DoubleTube |
| 10607411959612 | Salter Style® Nasal O2 Cannula (Neonatal), 7' (2.1 m) supply tube with thread grip |
| 00607411952609 | Salter Style Nasal O2 Cannula (Infant), 7' (2.1 m) supply tube |
| 10607411952590 | Salter Style® Nasal O2 Cannula (Premature), 7' (2.1 m) supply tube with thread grip |
| 10607411952576 | Patient Kit |
| 00607411952562 | Gas Sampling Line .050" ID x 120" Length PVC Male/Female Luer Lock Connectors 5.0u Hydrophobic F |
| 10607411951296 | DuraCheck Blood pressure cuff, reusable, adult - Single Tube |
| 10607411951203 | Patient Kit |
| 10607411951197 | Patient Kit |
| 10607411951173 | Adult. EtCO2/O2 Nasal Divided Cannula, SH342824 |
| 10607411951166 | Adult. EtCO2/O2 Nasal Divided Cannula, SH34282 |
| 10607411951159 | Adult. EtCO2/O2 Nasal Divided Cannula, P03082D |
| 00607411951145 | Adult. EtCO2/O2 Nasal Divided Cannula, SH34283 |
| 00607411951138 | Adult. EtCO2/O2 Nasal Divided Cannula, SH342824 |
| 10607411951098 | Patient Kit |
| 10607411951074 | Patient Kit |
| 10607411951036 | StatCheck Disposable Blood Pressure Cuff Child (11-22 cm) - Single Tube |
| 10607411951005 | Patient Cannula Kit |
| 00607411950988 | DuraCheck Blood pressure cuff, reusable, adult - Single Tube |
| 10607411950961 | Gas Sampling Line .040" ID x 96" Length PVC |
| 10607411950954 | Pediatric. O2/ETCO2 Filtered Nasal Divided Cannula |
| 10607411950947 | Infant. ETCO2 Filtered Nasal Sampling Cannula |
| 10607411950930 | Adult. ETCO2 Filtered Nasal Sampling Cannula |
| 10607411950923 | Pediatric. O2/ETCO2 Filtered Nasal Divided Cannula |
| 10607411950886 | Pediatric. ETCO2 Filtered Nasal Sampling Cannula |
| 10607411950015 | Oxygen Tubing Kit |
| 10607411950008 | Nasal Cannula (adult) Salter Style®, soft, with 7’ (2.1 m) supply tube |
| 10607411947367 | Adult. EtCO2/O2 Oral/Nasal Divided Cannula, male threadgrip CO2 connector. Adaptor (22 mm I.D |
| 10607411947350 | Adult. EtCO2/O2 Nasal Divided Cannula, male threadgrip CO2 connector. Adaptor 22 mm (ID) x 6 mm |