FDA UDI
In Commercial Distribution
🇺🇸 United States
TruCath Oasis
DI: 00850045818678
·
Model: RH1216S
·
HR PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- TruCath Oasis
- Primary DI
- 00850045818678
- Version / Model
- RH1216S
- Company Name
- HR PHARMACEUTICALS INC.
- Labeler DUNS
- 828918164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-21
- Public Version
- 1
- Public Version Date
- 2024-03-29
- Public Version Status
- New
- Public Device Record Key
- ac1a79f0-a73a-42e4-bee7-320199366717
Device Description
TruCath Oasis™ Ready-to-Use Hydrophilic Intermittent Catheter , Touch-free Sleeve, Straight tip, Soft 12 fr, 16" Length
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 |
|---|---|---|---|---|
| GBM | CATHETER, URETHRAL | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64266 | Intermittent urethral drainage catheter, non-antimicrobial, single-use | A flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50850045818673 | GS1 | Case | 10 | In Commercial Distribution | |
| Package | 10850045818675 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 00850045818678 | GS1 |
Customer Contacts
- Phone
- +1(717)252-1110 ext. 110
- [email protected]