FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PhaSeal Optima
DI: 00382905156281
·
Model: 515628
·
BD Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BD PhaSeal Optima
- Primary DI
- 00382905156281
- Version / Model
- 515628
- Catalog Number
- 515628
- Company Name
- BD Switzerland Sàrl
- Labeler DUNS
- 482631558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-19
- Public Version
- 1
- Public Version Date
- 2025-12-29
- Public Version Status
- New
- Public Device Record Key
- d695dea4-30a9-4be0-abbd-06d91c741840
Device Description
BD Phaseal™ Optima Spike Set (C180-O)
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
- Yes
- 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 |
|---|---|---|---|---|
| 64997 | Non-ISO80369 formatted bag access spike | A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382905156282 | GS1 | Pack or Inner Pack | 50 | In Commercial Distribution | |
| Primary | 00382905156281 | GS1 | ||||
| Package | 50382905156286 | GS1 | Case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250059 | 000 |