FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IBC Tubing Organizer (Non Sterile)
DI: 10814321020398
·
Model: 5020N
·
INTERNATIONAL BIOPHYSICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- IBC Tubing Organizer (Non Sterile)
- Primary DI
- 10814321020398
- Version / Model
- 5020N
- Company Name
- INTERNATIONAL BIOPHYSICS CORPORATION
- Labeler DUNS
- 788403103
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-07-15
- Public Version
- 7
- Public Version Date
- 2021-12-14
- Public Version Status
- Update
- Public Device Record Key
- 5f5cfb86-8f65-46a5-9b35-1ece8e6b7bc1
- Distribution End Date
- 2021-12-13
Device Description
The Tubing Organizer is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | Cardiovascular | 870.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62137 | Medical/surgical interventional tube/cable securement clip, single-use | A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10814321020398 | GS1 | ||||
| Unit of Use | 00814321020391 | GS1 |