FDA UDI
In Commercial Distribution
🇺🇸 United States
Dover
DI: 10884521007918
·
Model: 145546
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dover
- Primary DI
- 10884521007918
- Version / Model
- 145546
- Catalog Number
- 145546
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-22
- Public Version
- 2
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- f58e59d9-50ef-4cd8-a72e-9cc9bcd91ed2
Device Description
Enema Bucket and Tube,Pre-Lubricated Tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCE | Enema kit | Gastroenterology, Urology | 876.5210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35050 | Gravity enema set | A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521007915 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10884521007918 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1400 | Milliliter | |
| Length | 60 | Inch | |
| Catheter Gauge | 24 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;