FDA UDI
In Commercial Distribution
🇺🇸 United States
Vial2Bag Advanced® 13mm Admixture Device
DI: 07290108241433
·
Model: 6070034
·
WEST PHARMA. SERVICES IL, . LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vial2Bag Advanced® 13mm Admixture Device
- Primary DI
- 07290108241433
- Version / Model
- 6070034
- Catalog Number
- 6070034
- Company Name
- WEST PHARMA. SERVICES IL, . LTD
- Labeler DUNS
- 600267793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-23
- Public Version
- 1
- Public Version Date
- 2024-07-01
- Public Version Status
- New
- Public Device Record Key
- 71fdb6d9-7d98-4503-adb3-6c4ec8f17f8a
Device Description
Vial2Bag Advanced® 13mm Admixture 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
- 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
- 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 |
|---|---|---|---|---|
| 43324 | Fluid transfer set, general-purpose | A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. 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 | 17290108241430 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 07290108241433 | GS1 | ||||
| Package | 27290108241437 | GS1 | 3 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius