FDA UDI
In Commercial Distribution
🇺🇸 United States
SOMAVAC 100 Vacuum Source
DI: 00850004219010
·
Model: 20011
·
SOMAVAC MEDICAL SOLUTIONS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SOMAVAC 100 Vacuum Source
- Primary DI
- 00850004219010
- Version / Model
- 20011
- Catalog Number
- 20011
- Company Name
- SOMAVAC MEDICAL SOLUTIONS, INC.
- Labeler DUNS
- 080446796
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-30
- Public Version
- 2
- Public Version Date
- 2021-03-24
- Public Version Status
- Update
- Public Device Record Key
- 746c08bf-c8cc-4a6f-a976-27e464a17a45
Device Description
Portable battery powered vacuum source at 100mmHg
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | 878.4680 | 1 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64400 | Closed-wound drainage suction pump | A patient-worn, noninvasive, electrically-powered device intended to generate negative pressure for the continuous aspiration of surgical and/or bodily fluids from a closed-wound, via an in situ drain/catheter (not included), typically following a surgical procedure. It may include noninvasive accessories (e.g., collection bag), however it does not include invasive devices. It may be used in the home and in clinical settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850004219010 | GS1 |