FDA UDI
In Commercial Distribution
🇺🇸 United States
Vented Vial Adapter 20mm
DI: 07290108241129
·
Model: 8073039
·
WEST PHARMA. SERVICES IL, . LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vented Vial Adapter 20mm
- Primary DI
- 07290108241129
- Version / Model
- 8073039
- 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
- 2018-04-08
- Public Version
- 5
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- 0ae799da-0903-40dd-b59e-783372ab9f57
Device Description
Vented Vial Adapter 20mm FLL- VF
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
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 60822 | Medication transfer needle, filtering/vented | A slender, rigid, sharp or blunt, dual-lumen tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290108241123 | GS1 | 4 | In Commercial Distribution | ||
| Package | 17290108241126 | GS1 | 150 | In Commercial Distribution | ||
| Primary | 07290108241129 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062482 | 000 |