FDA UDI
In Commercial Distribution
🇺🇸 United States
Optimus Gravity Drainage Bag
DI: 00817640020554
·
Model: TC600
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Optimus Gravity Drainage Bag
- Primary DI
- 00817640020554
- Version / Model
- TC600
- Catalog Number
- TC600
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-04
- Public Version
- 4
- Public Version Date
- 2023-06-16
- Public Version Status
- Update
- Public Device Record Key
- 8962b4fb-c340-4284-8bdf-797387fca06e
Device Description
Optimus 600 Gravity Drainage Bag w/20" I.T.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EXF | Bag, Bile Collecting | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11301 | Closed-wound/centesis drainage receptacle | A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817640020551 | GS1 | Dispenser | 10 | In Commercial Distribution | 2028-05-01 |
| Primary | 00817640020554 | GS1 | ||||
| Package | 20817640020558 | GS1 | Shipper | 2 | In Commercial Distribution | 2028-05-01 |
| Previous | H862TC6000 | HIBCC | ||||
| Package | 30817640020555 | GS1 | Shipper | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 600 | Milliliter | |
| Length | 20 | Centimeter |