FDA UDI
In Commercial Distribution
🇺🇸 United States
Cook
DI: 00827002052680
·
Model: G05268
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cook
- Primary DI
- 00827002052680
- Version / Model
- G05268
- Catalog Number
- C-PLSY-901
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-02
- Public Version
- 2
- Public Version Date
- 2020-12-24
- Public Version Status
- Update
- Public Device Record Key
- b8e81eb2-919b-4d78-8082-565d27779335
Device Description
Peritoneal Lavage Tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GBW | CATHETER, PERITONEAL | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65232 | Peritoneal lavage catheterization support kit | A collection of devices, that includes a local anaesthetic agent, intended to support catheterization of the peritoneal space to enable lavage. It includes the pharmaceutical (e.g., lidocaine) and devices utilized for the procedure (e.g., scalpel, syringe, drapes); it does not include the peritoneal lavage catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002052680 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.