FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00763000059477
·
Model: 5873C
·
MEDTRONIC, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00763000059477
- Version / Model
- 5873C
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-28
- Public Version
- 1
- Public Version Date
- 2019-01-28
- Public Version Status
- New
- Public Device Record Key
- b854e4bd-82bc-4f96-9091-a1edc6871c4a
Device Description
SERVICE KIT 5873C OUS US EIFU
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OSR | Pacemaker/icd/crt non-implanted components | Unknown | 3 | |
| DTB | permanent pacemaker Electrode | Cardiovascular | 870.3680 | 3 |
| DXY | implantable pacemaker Pulse-generator | Cardiovascular | 870.3610 | 3 |
| NVZ | Pulse generator, permanent, implantable | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33500 | Pacing/defibrillation lead repair kit | A collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000059477 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890003 | 162 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius