| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00840241600047 | 80014-001 | 80014-001 | The ASSURE Wearable Cardioverter Defibrillator System | MVK | Wearable Automated External Defibrillator | 3 | ASSURE WCD System |
| 2 | 00840241600160 | 80016-005 | 80016-005 | The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 5 |
| 3 | 00840241600153 | 80016-004 | 80016-004 | The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 4 |
| 4 | 00840241600108 | 80015-006 | 80015-006 | The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 6 |
| 5 | 00840241600061 | 80015-002 | 80015-002 | The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 2 |
| 6 | 00840241600184 | 80016-007 | 80016-007 | The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 7 |
| 7 | 00840241600177 | 80016-006 | 80016-006 | The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 6 |
| 8 | 00840241600146 | 80016-003 | 80016-003 | The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 3 |
| 9 | 00840241600054 | 80015-001 | 80015-001 | The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 1 |
| 10 | 00840241600269 | 80433-002 | 80433-002 | CareStation Server acquires and displays data from the WCD for clinicians to view. | OUG | Medical Device Data System | 1 | CareStation Server |
| 11 | 00840241600191 | 80041-001 | 80041-001 | An electronic device used to program the ASSURE system and assist in patient fit An electronic device used to program the ASSURE system and assist in patient fitting and training | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Tablet |
| 12 | 00840241600122 | 80016-001 | 80016-001 | The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 1 |
| 13 | 00840241600023 | 80004-003 | 80004-003 | Provides the connection between the Garment and the Monitor | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Therapy Cable |
| 14 | 00840241600207 | 3326502-003 | 3326502-003 | A portable case that holds the Monitor while wearing the ASSURE system | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Carry Pack |
| 15 | 00840241600139 | 80016-002 | 80016-002 | The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that t The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style B, Size 2 |
| 16 | 00840241600092 | 80015-005 | 80015-005 | The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 5 |
| 17 | 00840241600085 | 80015-004 | 80015-004 | The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 4 |
| 18 | 00840241600252 | 80429-003 | 80429-003 | ASSURE patient app is a component of CareStation. | OUG | Medical Device Data System | 1 | ASSURE Patient Application |
| 19 | 00840241600016 | 3326633-004 | 3326633-004 | A separate device that charges the Battery | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Charger |
| 20 | 00840241600115 | 80015-007 | 80015-007 | The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 7 |
| 21 | 00840241600078 | 80015-003 | 80015-003 | The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that t The Style A, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin. | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Garment, Style A, Size 3 |
| 22 | 00840241600030 | 80008-003 | 80008-003 | A part of the ASSURE System that provides power and displays system status information | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Monitor |
| 23 | 00840241600009 | 3322882-005 | 3322882-005 | A rechargeable battery that powers the ASSURE System | MVK | Wearable Automated External Defibrillator | 3 | ASSURE, Battery |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00850015699016 | 43-5570-006-14 | After the surgery is completed, the OR Barcode Scanner can be used to scan the b After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. | OR Barcode Scanner | CANARY MEDICAL USA LLC | |
| 2 | 00850010298061 | com.ekodevices.android.intl | Eko mobile app for android international platforms for use with Eko medical devices. | Eko Mobile App Android International | EKO DEVICES, INC. | |
| 3 | 00841709118319 | M9D-042 / 9A682001 | M9D-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 4 | 00841709118296 | M9-042 / 9A682001 | M9-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 5 | 00841709118289 | M9-041 / 9A682001 | M9-041-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 6 | 00841709118272 | M9-040 / 9A682001 | M9-040-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 7 | 00841709118241 | M11-042 / 9A682001 | M11-042-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 8 | 00841709118234 | M11-041 / 9A682001 | M11-041-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 9 | 00841709118227 | M11-040 / 9A682001 | M11-040-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 10 | 00841492104698 | 354018 | Responder | RAULAND-BORG CORPORATION | ||
| 11 | 00841492104681 | 354017 | Responder | RAULAND-BORG CORPORATION | ||
| 12 | 00841492104667 | 354016 | Responder | RAULAND-BORG CORPORATION | ||
| 13 | 00841492104643 | 354015 | Responder | RAULAND-BORG CORPORATION | ||
| 14 | 00841492104612 | 354012 | Responder | RAULAND-BORG CORPORATION | ||
| 15 | 00841492104582 | 354011 | Responder | RAULAND-BORG CORPORATION | ||
| 16 | 00841492104575 | 354010 | Responder | RAULAND-BORG CORPORATION | ||
| 17 | 00841492104568 | 354002 | Responder | RAULAND-BORG CORPORATION | ||
| 18 | 00841492104513 | 354001WP | Responder | RAULAND-BORG CORPORATION | ||
| 19 | 00841492104490 | 354001 | Responder | RAULAND-BORG CORPORATION | ||
| 20 | 00841492104476 | 354000 | Responder | RAULAND-BORG CORPORATION | ||
| 21 | 00841492104452 | 353200 | Responder | RAULAND-BORG CORPORATION | ||
| 22 | 00841492104445 | 353101 | Responder | RAULAND-BORG CORPORATION | ||
| 23 | 00841492104438 | 353100 | Responder | RAULAND-BORG CORPORATION | ||
| 24 | 00841492104421 | 353010 | Responder | RAULAND-BORG CORPORATION | ||
| 25 | 00841492104384 | 353001 | Responder | RAULAND-BORG CORPORATION | ||
| 26 | 00841492104360 | 353000 | Responder | RAULAND-BORG CORPORATION | ||
| 27 | 00841492104353 | 352021 | Responder | RAULAND-BORG CORPORATION | ||
| 28 | 00841492104339 | 352010 | Responder | RAULAND-BORG CORPORATION | ||
| 29 | 00841492104322 | 352004 | Responder | RAULAND-BORG CORPORATION | ||
| 30 | 00841492104308 | 352000 | Responder | RAULAND-BORG CORPORATION | ||
| 31 | 00841492104285 | 351310 | Responder | RAULAND-BORG CORPORATION | ||
| 32 | 00841492104261 | 351300 | Responder | RAULAND-BORG CORPORATION | ||
| 33 | 00841492104254 | 351205 | Responder | RAULAND-BORG CORPORATION | ||
| 34 | 00841492104186 | 351004 | Responder | RAULAND-BORG CORPORATION | ||
| 35 | 00841492104179 | 351003 | Responder | RAULAND-BORG CORPORATION | ||
| 36 | 00841492104155 | 351001 | Responder | RAULAND-BORG CORPORATION | ||
| 37 | 00841492104148 | 351000 | Responder | RAULAND-BORG CORPORATION | ||
| 38 | 00841492104094 | 350300 | Responder | RAULAND-BORG CORPORATION | ||
| 39 | 00841492104087 | 350034 | Responder | RAULAND-BORG CORPORATION | ||
| 40 | 00841492103899 | 3225300 | Responder | RAULAND-BORG CORPORATION | ||
| 41 | 00841492103806 | 301103 | Responder | RAULAND-BORG CORPORATION | ||
| 42 | 00841492102564 | R5KURTA | Responder | RAULAND-BORG CORPORATION | ||
| 43 | 00841492102557 | R5KUPS1 | Responder | RAULAND-BORG CORPORATION | ||
| 44 | 00841492102533 | R5KUPB2 | Responder | RAULAND-BORG CORPORATION | ||
| 45 | 00841492102526 | R5KUCNL | Responder | RAULAND-BORG CORPORATION | ||
| 46 | 00841492102502 | R5KSSTF | Responder | RAULAND-BORG CORPORATION | ||
| 47 | 00841492102496 | R5KSMST | Responder | RAULAND-BORG CORPORATION | ||
| 48 | 00841492102489 | R5KSDTY | Responder | RAULAND-BORG CORPORATION | ||
| 49 | 00841492102472 | R5KPS1V | Responder | RAULAND-BORG CORPORATION | ||
| 50 | 00841492102465 | R5KPS1LCA | Responder | RAULAND-BORG CORPORATION |