FDA UDI
In Commercial Distribution
🇺🇸 United States
Heartsync by Vermed
DI: 00009336009619
·
Model: PED-100
·
GRAPHIC CONTROLS ACQUISITION CORP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Heartsync by Vermed
- Primary DI
- 00009336009619
- Version / Model
- PED-100
- Catalog Number
- 6600063H
- Company Name
- GRAPHIC CONTROLS ACQUISITION CORP
- Labeler DUNS
- 002111896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-17
- Public Version
- 3
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- bebcd7ae-1a96-45b6-9b1d-e464330830cb
Device Description
Defibrillator Electrodes
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | 870.5300 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | 50009336009614 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00009336009619 | GS1 |
Customer Contacts
- Phone
- 800-669-6905
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius