FDA UDI
In Commercial Distribution
🇺🇸 United States
Hollister
DI: 00610075093458
·
Model: 9345
·
HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Hollister
- Primary DI
- 00610075093458
- Version / Model
- 9345
- Catalog Number
- 9345
- Company Name
- HOLLISTER INCORPORATED
- Labeler DUNS
- 005527098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 2
- Public Version Date
- 2023-08-25
- Public Version Status
- Update
- Public Device Record Key
- 75615004-168f-4ff9-ad0a-03cb64a74de0
Device Description
Extension Tubing with connector
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| NNZ | SYSTEM, URINE DRAINAGE, CLOSED, FOR NON-INDWELLING CATHETER, NON-STERILE | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65173 | Urine drainage extension tubing | A length of noninvasive flexible tubing intended to connect between a patient contact urinary drainage device (e.g., urethral catheter, urostomy pouch) and a receptacle; some types may in addition be intended for extra-urinary passive drainage applications (e.g., intestinal ostomy or wound drainage). It is typically self-applied; it does not include a valve or clamp (i.e., not a tubing set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20610075093452 | GS1 | CAS | 4 | In Commercial Distribution | |
| Primary | 00610075093458 | GS1 | ||||
| Unit of Use | 00610075151202 | GS1 |
Customer Contacts
- Phone
- +1(800)323-4060
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 46 | Centimeter |