FDA UDI
In Commercial Distribution
🇺🇸 United States
SOMAVAC Belt Extender
DI: 00850004219065
·
Model: 20051
·
SOMAVAC MEDICAL SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SOMAVAC Belt Extender
- Primary DI
- 00850004219065
- Version / Model
- 20051
- Catalog Number
- 20051
- Company Name
- SOMAVAC MEDICAL SOLUTIONS, INC.
- Labeler DUNS
- 080446796
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-08
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 8a2f56cc-53f2-4542-b56f-293099d86d1a
Device Description
Extender for SOMAVAC Belt, 80 in.
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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31072 | Personal device holder, single-use | A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850004219062 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 00850004219065 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180606 | 000 |