FDA UDI
In Commercial Distribution
🇺🇸 United States
FloShield/Air
DI: 00815128020171
·
Model: FSS-02-1030T
·
MINIMALLY INVASIVE DEVICES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FloShield/Air
- Primary DI
- 00815128020171
- Version / Model
- FSS-02-1030T
- Catalog Number
- FSS-02-1030T
- Company Name
- MINIMALLY INVASIVE DEVICES, INC.
- Labeler DUNS
- 793517660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-25
- Public Version
- 3
- Public Version Date
- 2019-04-09
- Public Version Status
- Update
- Public Device Record Key
- 82062b74-8c8d-4f91-a44c-06d21ac271c0
Device Description
The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and debris deflection during minimally-invasive surgery while maintaining visualization of the surgical site.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61204 | Endoscope lens cleaner, gas/fluid, single-use | A sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815128020171 | GS1 | ||||
| Package | 10815128020178 | GS1 | Sales Box | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-614-340-3349
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter | |
| Lumen/Inner Diameter | 10 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 115 Degrees Fahrenheit