FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioseal Inc.
DI: 00630094175355
·
Model: 17535/50
·
BIOSEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bioseal Inc.
- Primary DI
- 00630094175355
- Version / Model
- 17535/50
- Company Name
- BIOSEAL
- Labeler DUNS
- 186968939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-28
- Public Version
- 1
- Public Version Date
- 2023-10-06
- Public Version Status
- New
- Public Device Record Key
- 08ea2180-83dc-41bf-b165-f3bd979659ec
Device Description
Medicine Cup
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYW | CONTAINER, LIQUID MEDICATION, GRADUATED | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12505 | Medicine cup, single-use | A cup specially designed for administering medicine to patients or disabled persons. It is made of disposable plastic and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10630094175352 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00630094175355 | GS1 |