FDA UDI
In Commercial Distribution
🇺🇸 United States
OnGuard2 20mm Vial Adaptor, 5 Units
DI: 27290115921872
·
Model: 412187
·
SIMPLIVIA HEALTHCARE LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
75
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Basic Information
- Brand Name
- OnGuard2 20mm Vial Adaptor, 5 Units
- Primary DI
- 27290115921872
- Version / Model
- 412187
- Company Name
- SIMPLIVIA HEALTHCARE LTD
- Labeler DUNS
- 521161349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2024-09-08
- Public Version
- 1
- Public Version Date
- 2024-09-16
- Public Version Status
- New
- Public Device Record Key
- 68e37d34-7436-4a09-acc3-9343677c834d
Device Description
OnGuard2 Vial Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to 20mm neck drug vial The device proximal end is intended to connect to OnGuard2 Syringe Adaptor (or Syringe Adaptor Lock)
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 |
|---|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41222 | Medication transfer set | A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37290115921879 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 27290115921872 | GS1 | ||||
| Unit of Use | 17290115921875 | GS1 |
Customer Contacts
- Phone
- +97246909710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192866 | 000 |