FDA UDI
In Commercial Distribution
🇺🇸 United States
GETINGE 46-SERIES
DI: 07340153710160
·
Model: 46-4
·
Getinge Disinfection AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GETINGE 46-SERIES
- Primary DI
- 07340153710160
- Version / Model
- 46-4
- Catalog Number
- 46-4-402K968
- Company Name
- Getinge Disinfection AB
- Labeler DUNS
- 354023236
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-06
- Public Version
- 3
- Public Version Date
- 2025-10-23
- Public Version Status
- Update
- Public Device Record Key
- 16d1b702-edd3-417e-8e21-281ce82d02ce
Device Description
WASHER DISINFECTOR 46-4 S+W D, configured as 46-4-402 (DI 07340153700031) but with alternate pump for distilled water.
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
- Yes
- 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 |
|---|---|---|---|---|
| MEC | Disinfector, Medical Devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66797 | Surgical instrument washer/disinfector (chemical/thermal) | An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07340153710160 | GS1 |