FDA UDI
In Commercial Distribution
🇺🇸 United States
Swabable Vial Adapter
DI: 07290108240351
·
Model: 8072001
·
WEST PHARMA. SERVICES IL, . LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Swabable Vial Adapter
- Primary DI
- 07290108240351
- Version / Model
- 8072001
- 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
- 2016-05-01
- Public Version
- 5
- Public Version Date
- 2019-03-18
- Public Version Status
- Update
- Public Device Record Key
- 52007cd0-9b2f-43a5-9072-c69fa739c8fc
Device Description
Vial Adapter 20mm Swabable - SF
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 |
|---|---|---|---|---|
| 58510 | Vial transfer spike | A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial’s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial’s contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290108240355 | GS1 | 4 | In Commercial Distribution | ||
| Package | 17290108240358 | GS1 | 125 | In Commercial Distribution | ||
| Primary | 07290108240351 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072511 | 000 |