FDA UDI
In Commercial Distribution
🇺🇸 United States
KENOREX
DI: 00810003751188
·
Model: 404087
·
KENTRON HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KENOREX
- Primary DI
- 00810003751188
- Version / Model
- 404087
- Catalog Number
- 404087
- Company Name
- KENTRON HEALTHCARE, INC.
- Labeler DUNS
- 618825723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-18
- Public Version
- 1
- Public Version Date
- 2018-12-19
- Public Version Status
- New
- Public Device Record Key
- 72a85db3-ab20-426a-a257-5e16401424d2
Device Description
VOMIT AND URINE WHITE BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" WIDE RIGID OPENING AT THE TOP.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FNY | Basin, Emesis | General Hospital | 880.6730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36258 | Emesis bag | A disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810003751201 | GS1 | CASE | 20 | In Commercial Distribution | |
| Package | 00810003751195 | GS1 | INNER BAG | 12 | In Commercial Distribution | |
| Primary | 00810003751188 | GS1 |