FDA UDI
In Commercial Distribution
🇺🇸 United States
OnGaurd2 CSTD Catheter Adaptor
DI: 27290115921827
·
Model: 412182
·
SIMPLIVIA HEALTHCARE LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- OnGaurd2 CSTD Catheter Adaptor
- Primary DI
- 27290115921827
- Version / Model
- 412182
- Company Name
- SIMPLIVIA HEALTHCARE LTD
- Labeler DUNS
- 521161349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-09-12
- Public Version
- 1
- Public Version Date
- 2023-09-20
- Public Version Status
- New
- Public Device Record Key
- d4434b4b-1f67-4725-9c49-e13e615225c6
Device Description
The product is part of OnGuard2 Chemfort system for use with Chemfort / OnGuard2 CSTD Syringe Adaptor / Syringe Adaptor Lock The distal end of the Catheter Adaptor connect to a urinary catheter The proximal end of e Catheter Adaptor connects to Syringe Adaptor / 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 | 37290115921824 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 27290115921827 | GS1 | ||||
| Unit of Use | 17290115921820 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231286 | 000 |