FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartStart
DI: 00884838002777
·
Model: 3-Wire Lead Set and Plug Snap IEC
·
Philips Medical Systems Hsg
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartStart
- Primary DI
- 00884838002777
- Version / Model
- 3-Wire Lead Set and Plug Snap IEC
- Catalog Number
- M3528A
- Company Name
- Philips Medical Systems Hsg
- Labeler DUNS
- 790605856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-04
- Public Version
- 5
- Public Version Date
- 2023-03-28
- Public Version Status
- Update
- Public Device Record Key
- 702ed0d8-e1a8-4af7-98fc-64fbff33390f
Device Description
3-wire lead set and plug, snap, (IEC)
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRO | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) | Cardiovascular | 870.5550 | 2 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35562 | Electrocardiographic lead set, reusable | A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838002777 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 158 Degrees Fahrenheit