FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Swabable Vented Vial Adapter
DI: 07290108240108
·
Model: 8073009
·
WEST PHARMA. SERVICES IL, . LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Swabable Vented Vial Adapter
- Primary DI
- 07290108240108
- Version / Model
- 8073009
- Company Name
- WEST PHARMA. SERVICES IL, . LTD
- Labeler DUNS
- 600267793
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-01
- Public Version
- 7
- Public Version Date
- 2023-06-30
- Public Version Status
- Update
- Public Device Record Key
- 00cb5e22-5ada-4920-a5af-c58cc1ea9464
- Distribution End Date
- 2017-01-01
Device Description
Vial Adapter 20mm Vented Swabable – 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
- Ethylene Oxide
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 | 27290108240102 | GS1 | 4 | Not in Commercial Distribution | 2017-01-01 | |
| Package | 17290108240105 | GS1 | 145 | Not in Commercial Distribution | 2017-01-01 | |
| Primary | 07290108240108 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072511 | 000 |