FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard® Rectal Tube
DI: 00801741045974
·
Model: 0006510
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Bard® Rectal Tube
- Primary DI
- 00801741045974
- Version / Model
- 0006510
- Catalog Number
- 0006510
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-16
- Public Version
- 4
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 768bad6e-c2ee-4d1f-bfc1-ace83561afcd
Device Description
Bard® Rectal Tube
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 14187 | Colonic lavage nozzle, single-use | A hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system/unit; it may additionally be intended for use with an enema kit for the delivery of an enema solution. It is typically designed as a one-piece, moulded nozzle that may have a bulb shape at the distal end to improve retention in the rectum and a barbed fitting at the proximal end for the attachment of the irrigation/enema tubing. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741045971 | GS1 | BX | 50 | In Commercial Distribution | |
| Primary | 00801741045974 | GS1 | ||||
| Package | 20801741045978 | GS1 | CA | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Inch | |
| Catheter Gauge | 24 | French |