Bard Button Replacement Gastrostomy Device
- Primary DI
- 10801741087889
- Brand
- Bard Button Replacement Gastrostomy Device
- Company
- Bard Access Systems, Inc.
- Model
- 000285
- Catalog number
- 000285
- Device description
- Button Kit
- Published
- 2015-09-24
- Public version status
- Update
- 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 |
|---|
| KGC | TUBE, GASTRO-ENTEROSTOMY |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10801741087889 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10801741087889 | 10801741087889 |
GMDN Terms
| Term | Definition |
|---|
| Gastrostomy button | A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Catheter Gauge | 24 | French |
| Length | 1.7 | Centimeter |
Regulatory Flags
- DUNS number
- 044611812
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- 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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