FDA UDI
In Commercial Distribution
🇺🇸 United States
Internal Handle
DI: 00847946022693
·
Model: 1011-0140-05-11
·
Zoll Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Internal Handle
- Primary DI
- 00847946022693
- Version / Model
- 1011-0140-05-11
- Company Name
- Zoll Medical Corporation
- Labeler DUNS
- 055363428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-21
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- d05d7442-3ee8-48d5-8566-c2401e8f28f2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 34943 | Internal defibrillation electrode, adult, reusable | An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop/start the heartbeat during cardiopulmonary surgery. It usually consists of a cable set with spoon-like electrodes (commonly known as internal defibrillator paddles or spoons) that are held by the operator directly to either side of the heart muscle so that the discharge passes directly through the heart. It is typically available as a set of two electrodes with insulated handles with a combined cable/connector. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847946022693 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042302 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 0 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 0 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- Low: 0 KiloPascal