FDA UDI
In Commercial Distribution
🇺🇸 United States
DLP®
DI: 20613994570486
·
Model: 10062
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- DLP®
- Primary DI
- 20613994570486
- Version / Model
- 10062
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-06-06
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fb32ee2e-e106-481a-bbfd-b11a7bb188d8
Device Description
SUCTION 10062 TUBE MINI 20FR 20PK 17L
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCY | APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | General, Plastic Surgery | 878.4680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate 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 | 20613994570486 | GS1 | ||||
| Unit of Use | 00613994570482 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950754 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9 FR Tapered Tip | ||
| Device Size Text, specify | 11 FR Shaft |