FDA UDI
In Commercial Distribution
🇺🇸 United States
CeraPlus
DI: 00610075099528
·
Model: 89002C
·
HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- CeraPlus
- Primary DI
- 00610075099528
- Version / Model
- 89002C
- Catalog Number
- 89002C
- Company Name
- HOLLISTER INCORPORATED
- Labeler DUNS
- 005527098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2026-03-01
- Public Version
- 1
- Public Version Date
- 2026-03-09
- Public Version Status
- New
- Public Device Record Key
- 05900fc4-b139-4c2b-8f5d-96c1ffc53a74
Device Description
1-Piece Drainable Ostomy Pouch Flat Skin Barrier Tape Kits
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PQE | Ostomy care kit | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62525 | Intestinal ostomy bag/support kit | A collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10610075099525 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00610075099528 | GS1 | ||||
| Unit of Use | 20610075099522 | GS1 |
Customer Contacts
- Phone
- +1(800)323-4060
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 64 | Millimeter |