FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Instavac I
DI: 08688250002580
·
Model: Instavac I
·
OHIO MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Instavac I
- Primary DI
- 08688250002580
- Version / Model
- Instavac I
- Company Name
- OHIO MEDICAL, LLC
- Labeler DUNS
- 005192885
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 5
- Public Version Date
- 2020-04-30
- Public Version Status
- Update
- Public Device Record Key
- aa988724-3bca-4f43-a1d0-eb1236a5152d
- Distribution End Date
- 2020-04-30
Device Description
Portable Suction Pump
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 63648 | General-purpose surgical suction system, electric | A portable assembly of devices, which includes a surgically invasive component, intended to aspirate body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy, urological surgical procedure); it may in addition have non-surgical applications. It is typically intended to remove debris, tissues and fluids, to clear a site and facilitate observation. It includes an electrically-powered suction pump, collection containers, tubing, and patient contact devices (e.g., handpiece/tip, catheter); it is not designed for irrigation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08688250002580 | GS1 |
Customer Contacts
- Phone
- 18478550500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933902 | 000 |