FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartStart
DI: 00884838023826
·
Model: FR2 Rechargeable Battery
·
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartStart
- Primary DI
- 00884838023826
- Version / Model
- FR2 Rechargeable Battery
- Catalog Number
- M3848A
- Company Name
- PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
- Labeler DUNS
- 079503890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-20
- Public Version
- 4
- Public Version Date
- 2023-02-13
- Public Version Status
- Update
- Public Device Record Key
- 881a3a75-e5dd-42a5-a14e-6367424a5ffe
Device Description
FR2+ Battery, rechargeable LiION
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
- 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 |
|---|---|---|---|---|
| 34158 | Secondary battery | A rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838023826 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity