FDA UDI
In Commercial Distribution
🇺🇸 United States
CollectEVAC
DI: 00841436104579
·
Model: 610-954
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- CollectEVAC
- Primary DI
- 00841436104579
- Version / Model
- 610-954
- Catalog Number
- 610-954
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-01-03
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- e31936da-9e24-4b7c-9973-794178f95774
Device Description
Sterile device with tubing and adapter for use with ACMI and STORZ/Wolf resectoscopes
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQT | EVACUATOR, GASTRO-UROLOGY | Gastroenterology, Urology | 876.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14301 | Urological irrigation set | A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841436104579 | GS1 | ||||
| Unit of Use | 80841436104575 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 17.8 | Centimeter | |
| Length | 18.3 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight