FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PhaSeal
DI: 00382905151064
·
Model: 515106
·
BD Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- BD PhaSeal
- Primary DI
- 00382905151064
- Version / Model
- 515106
- Catalog Number
- 515106
- Company Name
- BD Switzerland Sàrl
- Labeler DUNS
- 482631558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 5
- Public Version Date
- 2025-07-17
- Public Version Status
- Update
- Public Device Record Key
- 918b40e5-dc3b-49fb-9962-711756f3b968
Device Description
Protector (P50 Multi)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONB | Closed antineoplastic and hazardous drug reconstitution and transfer system | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60537 | Vial/bottle adaptor, hermetic | A device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382905151064 | GS1 | ||||
| Package | 50382905151069 | GS1 | Case | 150 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight