Medline
- Primary DI
- 40080196030898
- Brand
- Medline
- Company
- MEDLINE INDUSTRIES, INC.
- Model
- DYND12301
- Catalog number
- DYND12301
- Device description
- CATHETER,EXTERNAL,MALE,EXO,LTX,LG,35MM
- Published
- 2020-12-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NNX | DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 40080196030898 | Package | GS1 | 25 | In Commercial Distribution |
| 10080196030897 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 40080196030898 | 40080196030898 |
| 10080196030897 | 10080196030897 |
GMDN Terms
| Term | Definition |
|---|
| Cystographic/urethrographic catheter, male | A sterile, flexible or semi-rigid tube with one or more openings in the distal tip, designed to infuse a contrast medium into the male urethra, and possibly urinary bladder, for diagnostic radiographic imaging of the urethra and/or bladder. The imaging is typically used to delineate abnormalities of structure or function of the bladder and urethra, including the detection of vesicoureteral reflux and stress incontinence. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in cool, dry area. Protect from freezing, avoid excessive heat. |
Regulatory Flags
- DUNS number
- 025460908
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00792293301246 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301284 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301314 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301352 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301406 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
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