FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IBC Suction Wand (Non Sterile)
DI: 10814321020374
·
Model: 1990N
·
INTERNATIONAL BIOPHYSICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- IBC Suction Wand (Non Sterile)
- Primary DI
- 10814321020374
- Version / Model
- 1990N
- Company Name
- INTERNATIONAL BIOPHYSICS CORPORATION
- Labeler DUNS
- 788403103
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-07-11
- Public Version
- 6
- Public Version Date
- 2021-12-14
- Public Version Status
- Update
- Public Device Record Key
- 61ce641a-2a4f-41be-9197-9c1c561c5fc3
- Distribution End Date
- 2021-12-13
Device Description
The IBC Suction Wand is a component of Blood Recovery Suction Systems for use in open heart procedures, autologus blood recovery or blood suction. It is a disposable, single use component.
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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Primary | 10814321020374 | GS1 | ||||
| Unit of Use | 00814321020377 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963756 | 000 |