FDA UDI
In Commercial Distribution
🇺🇸 United States
Heart Sync T-CardiacSci-AED™ Pads
DI: 00868866000004
·
Model: T100-CS
·
HEART SYNC INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Heart Sync T-CardiacSci-AED™ Pads
- Primary DI
- 00868866000004
- Version / Model
- T100-CS
- Catalog Number
- T100-CS
- Company Name
- HEART SYNC INC
- Labeler DUNS
- 041356039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-16
- Public Version
- 3
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 8cfc6f72-c690-4c94-aadb-8088231b7bd2
Device Description
Can be used in place of Cardiac Science™ electrodes part # 9131-001. Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11130 | Electrode conductive skin pad, single-use | A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868866000004 | GS1 | ||||
| Package | 10868866000001 | GS1 | Box | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 104 Degrees Fahrenheit