FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Thopaz
DI: 07612367014205
·
Model: Thopaz
·
Medela AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Thopaz
- Primary DI
- 07612367014205
- Version / Model
- Thopaz
- Catalog Number
- 200.2219
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2025-08-22
- Public Version Status
- Update
- Public Device Record Key
- 82ed88d1-b5e0-4a67-84ff-e5c5b5676d93
- Distribution End Date
- 2025-08-21
Device Description
Thoracic Vacuum Pump 079.0000
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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 63645 | Thoracic suction pump | An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure specifically for aspiration of the pleural cavity and/or mediastinum. It is a dedicated device intended to remove fluids (e.g., blood), secretions, and air to allow for the normal expansion/function of the lungs and/or mediastinum. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., catheter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07612367014205 | GS1 |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130210 | 000 |