FDA UDI
In Commercial Distribution
🇺🇸 United States
Hollister
DI: 00610075097791
·
Model: 9779
·
HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- Hollister
- Primary DI
- 00610075097791
- Version / Model
- 9779
- Catalog Number
- 9779
- Company Name
- HOLLISTER INCORPORATED
- Labeler DUNS
- 005527098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2018-01-01
- Public Version
- 4
- Public Version Date
- 2022-11-24
- Public Version Status
- Update
- Public Device Record Key
- 871f632b-b851-46f6-bb99-3a02fea9576b
Device Description
Universal Catheter Access Port
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
- Yes
- 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 |
|---|---|---|---|---|
| 64085 | Non-ISO80369-standardized small-bore linear connector, reusable | A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with a connection at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20610075097795 | GS1 | CAS | 12 | In Commercial Distribution | |
| Primary | 00610075097791 | GS1 | ||||
| Unit of Use | 00610075082421 | GS1 |
Customer Contacts
- Phone
- +1(800)323-4060
- [email protected]