FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 10653160237488
·
Model: DT14475
·
CENTURION MEDICAL PRODUCTS CORPORATION
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
- Centurion
- Primary DI
- 10653160237488
- Version / Model
- DT14475
- Catalog Number
- DT14475
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-01
- Public Version
- 1
- Public Version Date
- 2022-01-10
- Public Version Status
- New
- Public Device Record Key
- cfb2109e-1b20-4f33-9ad2-8f2b8466dc4d
Device Description
DIALYSIS ON/OFF KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FKG | TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS | Gastroenterology, Urology | 876.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32142 | Haemodialysis start/stop set | A collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160237481 | GS1 | CASE | 25 | In Commercial Distribution | |
| Primary | 10653160237488 | GS1 |
Customer Contacts
- Phone
- +1(517)546-5400
- [email protected]