Quantum 51-000064-00
GUDID 05060434421845
ID 3/16" x Wall 1/16" (OD 5/16") 2.0m
SPECTRUM MEDICAL LIMITED
Cardiopulmonary bypass system air bubble/fluid level detector| Primary Device ID | 05060434421845 |
| NIH Device Record Key | d77c01d2-2688-417c-8c65-5a4d30afdfc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum |
| Version Model Number | Quantum Flow Sensor (QF01) |
| Catalog Number | 51-000064-00 |
| Company DUNS | 516398679 |
| Company Name | SPECTRUM MEDICAL LIMITED |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 76 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060434421845 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190282
FDA Product Code
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass |
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 | 2019-07-01 |
| Device Publish Date | 2019-06-21 |
On-Brand Devices [Quantum]
| 05060434420879 | Quantum Anesthetic Gas Sensor (QAN1) |
| 05060434421944 | Quantum Smart Occluder - Right Hand (QSOR) |
| 05060434420732 | Quantum Smart Occluder - Left hand (QSOL) |
| 05060434422125 | ID 1/2" x Wall 3/32" (OD 11/16") 3.0m |
| 05060434422118 | ID 3/8" x Wall 3/32" (OD 9/16") 3.0m |
| 05060434422101 | ID 1/4" x Wall 3/32" (OD 7/16") 3.0m |
| 05060434422095 | ID 1/4" x Wall 1/16" (OD 3/8") 3.0m |
| 05060434422088 | ID 3/16" x Wall 1/16" (OD 5/16") 3.0m |
| 05060434422019 | ID 1/2" x Wall 3/32"(OD11/16") 0.75m |
| 05060434422002 | ID 3/8" x Wall 3/32" (OD 9/16") 0.75m |
| 05060434421999 | ID 1/4" x Wall 3/32" (OD 7/16") 0.75m |
| 05060434421982 | ID 1/4" x Wall 1/16" (OD 3/8") 0.75m |
| 05060434421975 | ID 3/16" x Wall 1/16" (OD 5/16") 0.75m |
| 05060434421883 | ID 1/2" x Wall 3/32" (OD 11/16") 2.0m |
| 05060434421876 | ID 3/8" x Wall 3/32" (OD 9/16") 2.0m |
| 05060434421869 | ID 1/4" x Wall 3/32" (OD 7/16") 2.0m |
| 05060434421852 | ID 1/4" x Wall 1/16" (OD 3/8") 2.0m |
| 05060434421845 | ID 3/16" x Wall 1/16" (OD 5/16") 2.0m |
| 05060434422026 | Quantum Workstation Lite (QWSL) |
| 05060434422316 | Quantum Pump Frame 6 - Toronto (QPF6) |
| 05060434422262 | Quantum Pump Frame 5 - Charlotte (QPF5) |
| 05060434421838 | Quantum Centrifugal Drive High Pressure (QCD37) |
| 05060434421821 | Quantum Centrifugal Drive Medium Pressure (QCD22) |
| 05060434422972 | Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.5m (QF25) Right Angled |
| 05060434422965 | Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.5m (QF24) Right Angled |
| 05060434422958 | Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.5m (QF23) Right Angled |
| 05060434422941 | Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.5m (QF22) Right Angled |
| 05060434422934 | Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.5m (QF21)Right Angled |
| 05060434422927 | Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.6m (QF20) Right Angled |
| 05060434422910 | Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.6m (QF19) Right Angled |
| 05060434422903 | Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 0.6m (QF18) Right Angled |
| 05060434422897 | Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 0.6m (QF17) Right Angled |
| 05060434422880 | Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 0.6m (QF16) Right Angled |
| 05060434423276 | Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.2m (QF35) |
| 05060434423269 | Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.2m (QF34) |
| 05060434423252 | Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.2m (QF33) |
| 05060434423245 | Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.2m (QF32) |
| 05060434423238 | Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.2m (QF31) |
| 05060434423221 | Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.75m (QF30) Right Angled |
| 05060434423214 | Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.75m (QF29) Right Angled |
| 05060434423207 | Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 0.75m (QF28) Right Angled |
| 05060434423191 | Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 0.75m (QF27) Right Angled |
| 05060434423184 | Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 0.75m (QF26) Right Angled |
| 05060434422743 | Quantum Ventilation Module - NIST (Tube Mount) |
| 05060434422736 | Quantum Ventilation Module - DISS (Tube Mount) |
| 05060434422071 | Quantum Ventilation Module - DISS (Hook Mount) |
| 05060434422064 | Quantum Ventilation Module - NIST (Hook Mount) |
| 05060434423443 | Quantum Smart Occluder - Right Hand |
| 05060434423436 | Quantum Smart Occluder - Left hand |
| 05060434423122 | Quantum Pump Frame 5 - Charlotte |
Trademark Results [Quantum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98807712 not registered Live/Pending |
Into-Me-Sea LLC 2024-10-17 |
 QUANTUM 98804816 not registered Live/Pending |
QuantumADR LLC 2024-10-16 |
 QUANTUM 98719255 not registered Live/Pending |
Evolve Biologix Inc. 2024-08-27 |
 QUANTUM 98705080 not registered Live/Pending |
Intervet Inc. 2024-08-19 |
 QUANTUM 98650676 not registered Live/Pending |
Raynor Marketing Ltd. 2024-07-16 |
 QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
 QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
 QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
 QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
 QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
 QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
 QUANTUM 98276061 not registered Live/Pending |
Jayakumar, Philip 2023-11-17 |
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