FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoPulse Multi-Chemistry Battery Charger
DI: 00849111001977
·
Model: 100
·
Zoll Circulation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AutoPulse Multi-Chemistry Battery Charger
- Primary DI
- 00849111001977
- Version / Model
- 100
- Catalog Number
- 8700-0753-16
- Company Name
- Zoll Circulation, Inc.
- Labeler DUNS
- 799455241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-24
- Public Version
- 4
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- 3552ee5c-62e7-42b2-b182-fa20ba58ea0b
Device Description
Charges and automatically conditions two NiMH or Li-Ion batteries and automatically verifies battery charge level.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DRM | Compressor, Cardiac, External | Cardiovascular | 870.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17115 | Noninvasive device battery charger | An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849111001977 | GS1 |
Customer Contacts
- Phone
- 4085412140
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112998 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 95 Degrees Fahrenheit