FDA UDI
In Commercial Distribution
🇺🇸 United States
Du-O-Vac Canister
DI: 10856438007916
·
Model: DV-3-110
·
W. T. FARLEY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Du-O-Vac Canister
- Primary DI
- 10856438007916
- Version / Model
- DV-3-110
- Company Name
- W. T. FARLEY, INC.
- Labeler DUNS
- 063805113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-06-14
- Public Version
- 8
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 16b62287-def7-43f0-ab1e-b50c9b372186
Device Description
Collection Canister for Du-O-Vac, 10 Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDQ | BOTTLE, COLLECTION, VACUUM | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34858 | Surgical suction system collection container, single-use | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10856438007916 | GS1 | ||||
| Unit of Use | 00856438007919 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K781988 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Collection Canister for Du-O-Vac, 500 ML, One time Use, 10 Pack |