FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CardioMessenger II-S Kit GSM US
DI: 04035479136635
·
Model: 399729
·
BIOTRONIK SE & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CardioMessenger II-S Kit GSM US
- Primary DI
- 04035479136635
- Version / Model
- 399729
- Catalog Number
- 399729
- Company Name
- BIOTRONIK SE & Co. KG
- Labeler DUNS
- 315620229
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-14
- Public Version
- 4
- Public Version Date
- 2021-08-19
- Public Version Status
- Update
- Public Device Record Key
- f7b0c576-8a64-4569-b08a-7d1aafd871c8
- Distribution End Date
- 2021-08-18
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
- 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 |
|---|---|---|---|---|
| OSR | Pacemaker/icd/crt non-implanted components | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61438 | Cardiac pulse generator reader, home-use | An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. This is a home-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035479136635 | GS1 |
Customer Contacts
- Phone
- +1(888)345-0374
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal