FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard® Levin Tube
DI: 00801741045806
·
Model: 0044180
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Bard® Levin Tube
- Primary DI
- 00801741045806
- Version / Model
- 0044180
- Catalog Number
- 0044180
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 637ee05e-d1b8-4389-b5ec-5ea4fd7031c3
Device Description
Bard® Levin 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
- No
- 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 |
|---|---|---|---|---|
| FRQ | TUBE, LEVINE | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58985 | Gastric lavage kit | A collection of non-sterile devices intended to be used for the manual irrigation, washing, and evacuation of debris (toxic substances) from the stomach. It typically consists of supply/drain bags with lavage and ancillary tubing; activated charcoal may be included. The tubing is intended to be inserted into the nose or mouth of the patient to contact the gastric mucosa where fluids are introduced and removed using gravity. The device is typically used by healthcare providers in clinics and emergency/trauma departments. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801741045800 | GS1 | CA | 4 | In Commercial Distribution | |
| Package | 10801741045803 | GS1 | BX | 50 | In Commercial Distribution | |
| Primary | 00801741045806 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 18 | French | |
| Length | 50 | Inch |