FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartSite
DI: 10885403229022
·
Model: MV0528
·
YUKON MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SmartSite
- Primary DI
- 10885403229022
- Version / Model
- MV0528
- Catalog Number
- MV0528
- Company Name
- YUKON MEDICAL, LLC
- Labeler DUNS
- 963361170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-06
- Public Version
- 4
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 69a9e72e-fa43-463a-b7c4-17edb91935f5
Device Description
CareFusion SmartSite VialShield 28mm Closed Vial Access Device
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
- Yes
- 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 |
|---|---|---|---|---|
| LHI | Set, i.V. Fluid transfer | 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 |
|---|---|---|---|---|---|---|
| Package | 50885403229020 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 10885403229022 | GS1 |
Customer Contacts
- Phone
- +1(888)812-3266
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 28 | Millimeter |