CARDINAL HEALTH
- Primary DI
- 50195594093622
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- SBA18CTAM2
- Catalog number
- SBA18CTAM2
- Device description
- 35043, CATHETER INSERTION
- Published
- 2021-05-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| OHR | Catheter care tray |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OHR | Catheter Care Tray | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 50195594093622 | Package | GS1 | 4 | In Commercial Distribution |
| 10195594093624 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 50195594093622 | 50195594093622 |
| 10195594093624 | 10195594093624 |
GMDN Terms
| Term | Definition |
|---|---|
| Urological surgical procedure kit, non-medicated, single-use | A collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 961027315
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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|---|---|---|---|---|
| 10192253047967 | Kendall | 9233 | 9233- | 2026-05-26 |
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| 20192253019992 | Kendall | 33547T | 33547T-- | 2026-05-26 |
| 20885380136617 | CARDINAL HEALTH | N8830 | N8830 | 2019-02-07 |
| 20885380136624 | CARDINAL HEALTH | N8831 | N8831 | 2019-02-07 |
| 20885380136631 | CARDINAL HEALTH | N8832 | N8832 | 2019-02-07 |
| 20885380168069 | CARDINAL HEALTH | C3660PPL | C3660PPL | 2019-04-30 |
| 10192253045093 | Kendall | MK00175 | MK00175 | 2023-06-15 |
| 10192253013016 | Argyle | 8888750018 | 8888750018 | 2022-10-26 |
| 10192253013023 | Argyle | 8888750513 | 8888750513 | 2022-10-26 |
| 10198956056497 | CARDINAL HEALTH | PN69MSGAD | PN69MSGAD | 2026-05-25 |
| 10198956057005 | CARDINAL HEALTH | SBACGDPMED | SBACGDPMED | 2026-05-25 |
| 10198956221161 | CARDINAL HEALTH | SOP29PLCCY | SOP29PLCCY | 2026-05-25 |
| 10198956253773 | CARDINAL HEALTH | SOP56TKTCC | SOP56TKTCC | 2026-05-25 |
| 10198956257610 | CARDINAL HEALTH | SOPOCTKLHK | SOPOCTKLHK | 2026-05-25 |
| 10198956258730 | CARDINAL HEALTH | AMN4Q8277C | AMN4Q8277C | 2026-05-25 |
| 10198956291812 | CARDINAL HEALTH | SOP4FKPWFB | SOP4FKPWFB | 2026-05-25 |
| 10198956300316 | CARDINAL HEALTH | 34-2071H | 34-2071H | 2026-05-25 |
| 10198956321632 | CARDINAL HEALTH | SOPCGKHAUC | SOPCGKHAUC | 2026-05-25 |
| 10198956325487 | CARDINAL HEALTH | PO43LEUNC | PO43LEUNC | 2026-05-25 |
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| 50850045818482 | TruAdvance® | HR PHARMACEUTICALS INC. | OHR | 2025-12-22 |
| 00850063139366 | Neil Medical Group | Neil Medical Group | OHR | 2025-12-08 |
| 00850063139373 | Neil Medical Group | Neil Medical Group | OHR | 2025-12-08 |
| 00850063139380 | Neil Medical Group | Neil Medical Group | OHR | 2025-12-08 |
| 00850063139397 | Neil Medical Group | Neil Medical Group | OHR | 2025-12-08 |
| 50198956214567 | CARDINAL HEALTH | Cardinal Health 200, LLC | OHR | 2025-11-28 |
| 50850058254888 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254895 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254901 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254918 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254925 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254932 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254949 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254956 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50850058254963 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-09-11 |
| 50198956094374 | CARDINAL HEALTH | Cardinal Health 200, LLC | OHR | 2025-08-25 |
| 50850058254765 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-08-11 |
| 50850058254970 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-08-11 |
| 50850058254987 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-08-11 |
| 50850058254857 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-08-05 |
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| 50850058254826 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-07-25 |
| 50850058254833 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-07-25 |
| 50850058254840 | TruAdvance | HR PHARMACEUTICALS INC. | OHR | 2025-07-25 |
| 10854913006171 | Intravesical Administration Kit | UROGEN PHARMA LTD | OHR | 2025-06-16 |