FDA Registration
Active
🇺🇸 United States
Resource Optimization & Innovation, LLC
Reg #: 3004513970
·
FEI: 3004513970
·
Expires 2026
Products
40
Proprietary Names
1
Establishment Types
1
Classifications
40
Registration Details
- Registration Name
- Resource Optimization & Innovation, LLC
- Registration Number
- 3004513970
- FEI Number
- 3004513970
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1100 Dr Martin L King Jr Blvd Ste 1100
- City
- Nashville
- State
- TN
- ZIP
- 37203
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093169
Owner / Operator
- Firm Name
- Resource Optimization & Innovation
- Operator Number
- 10026387
- Address
- 1100 Dr. Martin Luther King Jr. Blvd, Suite 1100
- City
- Nashville
- State
- TN
- Postal Code
- 37203
- Country
- US
- Correspondent
- Karen Wagener
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2019-09-26 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2023-02-15 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2016-04-14 |
| Bag, Polymeric Mesh, Pacemaker | DSW | Class 1 | Cardiovascular | No | 2026-02-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-09-10 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-03-16 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2026-03-03 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2019-09-26 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2024-11-15 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2019-09-26 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2019-09-26 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2024-01-25 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-07-14 |
| Central Venous Catheter Tray | OFF | Class 2 | Cardiovascular | No | 2019-09-26 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-11-29 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2024-05-15 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2019-09-26 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2019-09-26 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-12-19 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2023-02-02 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2009-10-20 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2019-09-26 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2019-09-26 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-07-13 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2020-07-13 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2020-07-13 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2008-08-06 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2022-11-07 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-03-16 |
| Circumcision Tray | OHG | Class 2 | Obstetrics/Gynecology | No | 2008-08-06 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2023-11-29 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2019-09-26 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2019-11-06 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2022-08-23 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2023-04-14 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2019-09-26 |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | Class 2 | General, Plastic Surgery | No | 2024-05-15 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-03-16 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2026-03-09 |
| Arterial Blood Sampling Kit | CBT | Class 1 | Anesthesiology | No | 2022-05-18 |
Proprietary Names
Regard
Establishment Types
Repack or Relabel Medical Device