FDA UDI
In Commercial Distribution
🇺🇸 United States
TrueCPR™ Coaching Device
DI: 00883873890455
·
Model: 80596
·
PHYSIO-CONTROL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TrueCPR™ Coaching Device
- Primary DI
- 00883873890455
- Version / Model
- 80596
- Catalog Number
- 80596-000003
- Company Name
- PHYSIO-CONTROL, INC.
- Labeler DUNS
- 009251992
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- abd7e219-fcc4-44dc-9b0d-3eebdecc9c93
Device Description
TRUECPR,PACKAGED,MULTI-LANGUAGE, CONFIG B
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIX | AID, CARDIOPULMONARY RESUSCITATION | Cardiovascular | 870.5210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60368 | Cardiopulmonary resuscitation feedback device, electronic | A portable, battery-powered device intended to provide real-time feedback on manual chest compressions (i.e., depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compressions and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00883873890455 | GS1 |
Customer Contacts
- Phone
- +1(800)442-1142
- [email protected]