HeartStart M5530A
GUDID 00884838021945
Combiner plug for 3-wire lead set
Philips Medical Systems Hsg
Electrocardiographic lead set, reusable| Primary Device ID | 00884838021945 |
| NIH Device Record Key | f3b8401a-c5a2-465c-92de-7c85d945eb26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartStart |
| Version Model Number | Combiner Plug for 3-Wire Lead Set |
| Catalog Number | M5530A |
| Company DUNS | 790605856 |
| Company Name | Philips Medical Systems Hsg |
| 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 | 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838021945 [Primary] |
FDA Product Code
| MKJ | Automated External Defibrillators (Non-Wearable) |
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 | 2024-10-03 |
| Device Publish Date | 2024-09-25 |
Devices Manufactured by Philips Medical Systems Hsg
| 00884838009486 - Paper | 2024-12-19 Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs ( |
| 00884838123717 - Care Assist | 2024-12-05 Care Assist |
| 00884838123724 - Care Assist | 2024-12-05 Care Assist |
| 00884838021945 - HeartStart | 2024-10-03Combiner plug for 3-wire lead set |
| 00884838021945 - HeartStart | 2024-10-03 Combiner plug for 3-wire lead set |
| 00884838113978 - Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets | 2024-09-24 3-Lead Set, disposable, for single patient use, to measure bedside ECG. AAMI color coded grabbers. Round (rd) peelable ribbon st |
| 00884838114012 - Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets | 2024-09-24 5-Lead Set, disposable, for single patient use, to measure bedside ECG. AAMI color coded grabbers. Round (rd) peelable ribbon st |
| 00884838114029 - Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets | 2024-09-24 6-Lead Set, disposable, for single patient use, to measure bedside ECG. AAMI color coded grabbers. Round (rd) peelable ribbon st |
| 00884838114036 - Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets | 2024-09-24 5-Lead Set, disposable, for single patient use, with protective shield, to measure ECG on IntelliVue Telemetry. AAMI color coded |
Trademark Results [HeartStart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTSTART 73609215 1454082 Live/Registered |
LAERDAL MEDICAL CORPORATION 1986-07-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.