FDA UDI
In Commercial Distribution
🇺🇸 United States
Crono
DI: 08050616612021
·
Model: Super PID
·
CANE' SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Crono
- Primary DI
- 08050616612021
- Version / Model
- Super PID
- Company Name
- CANE' SPA
- Labeler DUNS
- 438017964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-21
- Public Version
- 6
- Public Version Date
- 2024-08-07
- Public Version Status
- Update
- Public Device Record Key
- ad2ff016-3c8c-4f13-9cca-7eb1fbbba362
Device Description
The CRONO Super PID is an ambulatory syringe infusion pump intended for the controlled, subcutaneous administration of liquids.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FRN | Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61514 | Ambulatory non-insulin infusion pump, electronic | A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08050616612038 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 08050616612021 | GS1 |
Customer Contacts
- Phone
- (630) 845-7867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052217 | 000 |