FDA UDI
In Commercial Distribution
🇺🇸 United States
Cook CollectEVAC
DI: 00827002515499
·
Model: CCE-10
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cook CollectEVAC
- Primary DI
- 00827002515499
- Version / Model
- CCE-10
- Catalog Number
- G51549
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- c9bcef24-2358-4b30-bb58-0a49b4f4a0e3
Device Description
Cook CollectEVAC
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 | 00827002515499 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 18.3 | Centimeter | |
| Height | 17.8 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight