FDA UDI
In Commercial Distribution
🇺🇸 United States
New Image
DI: 00610075095728
·
Model: 18754
·
HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
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Basic Information
- Brand Name
- New Image
- Primary DI
- 00610075095728
- Version / Model
- 18754
- Catalog Number
- 18754
- Company Name
- HOLLISTER INCORPORATED
- Labeler DUNS
- 005527098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2024-12-19
- Public Version
- 1
- Public Version Date
- 2024-12-27
- Public Version Status
- New
- Public Device Record Key
- b9c96f05-f013-4699-9bc1-eababb99efe6
Device Description
2-Piece Closed Ostomy Pouch
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
- Yes
- 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 |
|---|---|---|---|---|
| EXB | Collector, ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31067 | Multiple-piece intestinal ostomy bag, closed-ended | A plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The base plate remains attached around the stoma, typically for 2 to 3 days, when the pouch is removed and replaced. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20610075111163 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00610075095728 | GS1 | ||||
| Unit of Use | 30610075111160 | GS1 |
Customer Contacts
- Phone
- +1(800)323-4060
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 70 | Millimeter |