FDA UDI
In Commercial Distribution
🇺🇸 United States
Convenience Bag
DI: 00810050854252
·
Model: 7000HPE
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Convenience Bag
- Primary DI
- 00810050854252
- Version / Model
- 7000HPE
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-11
- Public Version
- 1
- Public Version Date
- 2022-11-21
- Public Version Status
- New
- Public Device Record Key
- 98f6ac30-db1a-45c4-8889-78d2b75fe3ed
Device Description
Convenience Bag with Hand Protection, EU (White)
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 | 10810050854259 | GS1 | Case | 240 | In Commercial Distribution | |
| Primary | 00810050854252 | GS1 |