FDA UDI
In Commercial Distribution
🇺🇸 United States
Vario 18 AC
DI: 07612367052443
·
Model: 026.0007
·
Medela AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vario 18 AC
- Primary DI
- 07612367052443
- Version / Model
- 026.0007
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 4
- Public Version Date
- 2023-08-28
- Public Version Status
- Update
- Public Device Record Key
- 49ec0bb2-9718-4088-b108-8f7e3136240c
Device Description
Powered suction pump Overflow protection filter Silicone tubing PSU jar 0.25l Lid to PSU jar Disposable tubing
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63642 | Surgical suction pump | An electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07612367052443 | GS1 |
Customer Contacts
- Phone
- 1-877-735-1626
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153663 | 000 |