FDA UDI
In Commercial Distribution
🇺🇸 United States
TruCath
DI: 00850025153294
·
Model: HC0810
·
HR PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TruCath
- Primary DI
- 00850025153294
- Version / Model
- HC0810
- Catalog Number
- HC0810
- Company Name
- HR PHARMACEUTICALS INC.
- Labeler DUNS
- 828918164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-08
- Public Version
- 1
- Public Version Date
- 2023-05-16
- Public Version Status
- New
- Public Device Record Key
- 649304dd-53c8-469b-85ca-ab8a52f84cef
Device Description
Pediatric Hydro Coude 8FR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GBM | CATHETER, URETHRAL | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36125 | Urine-sampling urethral catheter | A sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to connect to a urine specimen collection container. The device is applied by a healthcare provider to the patient, is typically made of polyvinyl chloride (PVC), and may or may not be coated with a lubricating substance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850025153291 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 00850025153294 | GS1 | ||||
| Package | 50850025153299 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(717)252-1110 ext. 110
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111405 | 000 |