MEDLINE
- Primary DI
- 20193489198253
- Brand
- MEDLINE
- Company
- MEDLINE INDUSTRIES, INC.
- Model
- DYNDA2544
- Catalog number
- DYNDA2544
- Device description
- 3WAY LF CATHETER KIT
- Published
- 2020-10-06
- 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
Product Codes
| Code | Name |
|---|
| FCN | Urinary drainage collection kit, for indwelling catheter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20193489198253 | Package | GS1 | 20 | In Commercial Distribution |
| 10193489198256 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 20193489198253 | 20193489198253 |
| 10193489198256 | 10193489198256 |
GMDN Terms
| Term | Definition |
|---|
| General surgical procedure kit, medicated | A general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device. |
Regulatory Flags
- DUNS number
- 025460908
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- true
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- 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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| 00850053289088 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
| 00850053289095 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
| 00850053289101 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
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| 10350770003402 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
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| 10350770003426 | NEOMED* | Avanos Medical, Inc. | FCN | 2021-08-27 |
| 10851616002462 | SteriGear | Sterigear, LLC | FCN | 2021-05-11 |
| 10851616002561 | SteriGear | Sterigear, LLC | FCN | 2021-05-11 |
| 10851616002585 | SteriGear | Sterigear, LLC | FCN | 2021-05-11 |
| 50885380176706 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
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| 50885380176720 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 50885380176737 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 10851616002028 | SteriGear | Sterigear, LLC | FCN | 2020-11-17 |
| 10851616002035 | SteriGear | Sterigear, LLC | FCN | 2020-11-17 |
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