FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard Stoma Measuring Device
DI: 00801741081149
·
Model: 000842
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Bard Stoma Measuring Device
- Primary DI
- 00801741081149
- Version / Model
- 000842
- Catalog Number
- 000842
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-18
- Public Version
- 4
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 6d242878-95d5-4402-8473-bc28610fec42
Device Description
Bard Stoma Measuring Device 18F/24F
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
- No
- 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 |
|---|---|---|---|---|
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63943 | Stomal diameter sizer | A device intended to be used to measure the diameter of a stomal opening at the body surface to help in the selection of an appropriately-sized stomal appliance (e.g., ostomy bag). It is typically in the form of a paper/plastic sheet with holes of graduated sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801741081143 | GS1 | BX | 36 | In Commercial Distribution | |
| Package | 10801741081146 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741081149 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 24 | French | |
| Catheter Gauge | 18 | French |