Primary Device ID | 10190752111288 |
NIH Device Record Key | 855495fd-abb7-4f7b-86ec-16f29d5442de |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Vital Signs™ |
Version Model Number | 545327-HEL |
Catalog Number | 545327-HEL |
Company DUNS | 368457563 |
Company Name | Vyaire Medical Oy |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10190752111288 [Primary] |
DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-06-06 |
Device Publish Date | 2018-11-23 |
20190752109275 | Breathing Circuit, Pediatric, Disposable, 3.75 m/150 in With Manual Bag, 1 L, Gas Sampling Elbow |
20190752109244 | Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 750/S, |
20190752109206 | Patient Circuit, Expandable, Pediatric, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Uni-Fi |
20190752109190 | Co-axial Circuit, Adult, Disposable 1.5 m/60 in With Gas Sampling Elbow, HMEF 750/S and Manual B |
20190752109183 | Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 750, Ma |
20190752109176 | Co-axial Breathing Circuit, Adult, Disposable, 1.8 m/72 in With Gas Sampling Elbow, HMEF 750/S, |
20190752109169 | Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Manual B |
20190752109114 | Breathing Circuit, Expandable, Adult, Disposable, 3.0m/120 in With HMEF 750/S, Gas Sampling Elbo |
20190752109084 | Co-axial Breathing Circuit, Adult, Disposable, 1.8m/72 in With Elbow, Manual Bag, 3 L, HMEF 750/ |
20190752109077 | Breathing Circuit, Adult, Expandable, Disposable, 3.0m/120 in With Unifilter Junior, Gas Samplin |
20190752109053 | Breathing Circuit, Expandable, Adult, Disposable, 3 m/120 in With HMEF 750/s, Gas Sampling Elbow |
20190752109046 | Breathing Circuit, Expandable, Adult, Disposable, 2.4 m/96 in With HMEF 750/S, Gas Sampling Elbo |
20190752109008 | Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Manual B |
20190752108995 | Breathing Circuit, Expandable, Pediatric, Disposable, 1.8 m/72 in With Gas Sampling Elbow, Gas S |
20190752108988 | Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With HMEF1000, Gas Sampling Elbow |
20190752109237 | Breathing Circuit Components, HMEF Mini/s with Elbow, Disposable |
20190752109213 | Breathing Circuit Components, HMEF 750/S with Elbow, Disposable |
50190752110760 | CAPNOSTAT Pediatric/Infant Airway Adapter, Disposable |
50190752110753 | CAPNOSTAT Adult/Pediatric Airway Adapter, Disposable |
10190752110731 | Vital Signs CAPNOSTAT Pediatric/Infant Airway Adapter, Reusable |
10190752110724 | Vital Signs CAPNOSTAT Adult/Pediatric Airway Adapter, Reusable |
50190752110708 | Sampling Line with Male Luer and Dehumidification Tubing for CapnoFlex Module |
50190752110692 | Sampling Line with Male Luer for CapnoFlex Module |
50190752110685 | Infant/Neonatal Airway Adapter with Dehumidification Tubing for CapnoFlex Module |
50190752110678 | Adult/Pediatric Airway Adapter with Dehumidification Tubing for CapnoFlex Module |
50190752110661 | Infant/Neonatal Airway Adapter for CapnoFlex Module |
50190752110654 | Adult /Pediatric Airway Adapter for CapnoFlex Module |
50190752110647 | Pediatric Oral/Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module |
50190752110630 | Adult Oral/Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module |
50190752110623 | Pediatric Oral/Nasal CO2 Sampling Cannula for CapnoFlex Module |
50190752110616 | Adult Oral/Nasal CO Sampling Cannula for CapnoFlex Module |
50190752110609 | Infant/Neonatal Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module |
50190752110593 | Pediatric Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module |
50190752110586 | Adult Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module |
50190752110579 | Infant/Neonatal Nasal CO2 Sampling Cannula for CapnoFlex Module |
10190752110564 | Pediatric Nasal CO2 Sampling Cannula for CapnoFlex Module |
50190752110555 | Adult Nasal CO2 Sampling Cannula for CapnoFlex Module |
10190752179356 | Cardiac Output Care Cable for GE Monitors, 2.7 m/8 ft |
10190752179349 | Cardiac Output Care Cable for GE Monitors, 3.6 m/12 ft |
10190752179318 | Direct Connect Temperature Cable for GE Monitors, 400 Series, Dual, 3.6 m/12 ft |
10190752179301 | Direct Connect Temperature Cable for GE Monitors, 400 Series, Single, 3.6 m/12 ft |
10190752179295 | Temperature Cable for GE Monitors, 400 Series, Single, 0.5 m / 20 in |
10190752179288 | Invasive Blood Pressure Cable, For use with EDWARDS Lifesciences TRUWAVE, Dual, 3.6 m/12 ft |
10190752179271 | Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Single, 3.6 m/12 ft |
10190752179264 | Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Dual, 3.6 m/12 ft |
10190752179257 | Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Single, 3.6 m/12 ft |
10190752179097 | Temperature Cable for GE Monitors, 400 Series, Dual, 0.5 m / 20 in |
10190752179080 | Invasive Blood Pressure Cable, For use with Utah/Biotrans, Dual, 3.6 m/12 ft |
10190752179073 | Invasive Blood Pressure Cable, For use with Utah/Biotrans, Single, 3.6 m/12 ft |
10190752179066 | Invasive Blood Pressure Cable, For use with Merit Medical Meritrans DTXPlus, Dual, 3.6 m/12 ft |