FDA UDI
In Commercial Distribution
🇺🇸 United States
TruCath
DI: 00850058254814
·
Model: D10020
·
HR PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- TruCath
- Primary DI
- 00850058254814
- Version / Model
- D10020
- Company Name
- HR PHARMACEUTICALS INC.
- Labeler DUNS
- 828918164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-16
- Public Version
- 1
- Public Version Date
- 2025-01-24
- Public Version Status
- New
- Public Device Record Key
- 71e8b97b-b0ab-4856-ba9e-8bcd33167c93
Device Description
TruCath® Duo™ Dual Balloon Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| EZL | CATHETER, RETENTION TYPE, BALLOON | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44707 | Device-irrigation sterile water | A fluid consisting of sterile water (H2O) that is used exclusively for the cleaning and irrigation of a device (e.g., a Foley catheter or a tracheobronchial suction catheter). It is not intended for wound irrigation or injection or intravenous (IV) administration. The device is usually available in a plastic container or bottle of various sizes. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850058254811 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00850058254814 | GS1 | ||||
| Package | 50850058254819 | GS1 | Case | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(717)252-1110 ext. 110
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius