FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PhaSeal
DI: 30382905150051
·
Model: 515005
·
BD Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
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Basic Information
- Brand Name
- BD PhaSeal
- Primary DI
- 30382905150051
- Version / Model
- 515005
- Catalog Number
- 515005
- Company Name
- BD Switzerland Sàrl
- Labeler DUNS
- 482631558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2024-09-23
- Public Version Status
- Update
- Public Device Record Key
- 9d691b05-b4b2-4596-9a78-15b926cc85dc
Device Description
Injector Luer Lock (N35C 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
- 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 |
|---|---|---|---|---|
| 60538 | Luer/Luer linear connector, single-use | A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382905150051 | GS1 | ||||
| Unit of Use | 00382905150050 | GS1 | ||||
| Package | 50382905150055 | GS1 | Case | 250 | In Commercial Distribution |