FDA UDI
In Commercial Distribution
🇺🇸 United States
COX RAPIDHEAT
DI: B234KMHCX6220230V152
·
Model: 6220
·
CPAC EQUIPMENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COX RAPIDHEAT
- Primary DI
- B234KMHCX6220230V152
- Version / Model
- 6220
- Catalog Number
- COX-230V-15
- Company Name
- CPAC EQUIPMENT, INC.
- Labeler DUNS
- 601985976
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 1
- Public Version Date
- 2018-09-24
- Public Version Status
- New
- Public Device Record Key
- 5d1be7c7-8f22-4d60-a1e0-956500ddc3e7
Device Description
HIGH VELOCITY HOT AIR STERILIZER - 230V
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KMH | Sterilizer, Dry Heat | General Hospital | 880.6870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35364 | Dry-heat sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a heat source (e.g., electric heaters); and controls to regulate the time and/or temperature of the procedure. The heat may flow into the chamber either by natural convection or using forced air to accelerate and/or make more uniform the process (e.g., fans, high-speed hot air jets). The device is available in stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B234KMHCX6220230V152 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K881371 | 000 |