FDA UDI
In Commercial Distribution
🇺🇸 United States
Suction tip
DI: 00803622105883
·
Model: SU-xxxxx
·
LIVANOVA USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Suction tip
- Primary DI
- 00803622105883
- Version / Model
- SU-xxxxx
- Company Name
- LIVANOVA USA, INC.
- Labeler DUNS
- 080914995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-16
- Public Version
- 6
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- bd7dae47-660e-4e44-8ef2-d45a88f25c11
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| DTS | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35917 | Surgical/emergency suction cannula, non-illuminating, single-use | An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10803622105880 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 00803622105883 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982891 | 000 |