FDA UDI
In Commercial Distribution
🇺🇸 United States
TUBING ORGANIZER - STERILE
DI: B0663110330000
·
Model: 311033-000
·
NOVOSCI CORP.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- TUBING ORGANIZER - STERILE
- Primary DI
- B0663110330000
- Version / Model
- 311033-000
- Catalog Number
- 311033-000
- Company Name
- NOVOSCI CORP.
- Labeler DUNS
- 938289980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-06
- Public Version
- 4
- Public Version Date
- 2023-06-20
- Public Version Status
- Update
- Public Device Record Key
- f98cd19d-b148-4b67-9924-5edd4aab2f6a
Device Description
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.
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | B0663110330005 | HIBCC | OUTER SHIPPER | 40 | In Commercial Distribution | |
| Primary | B0663110330000 | HIBCC | ||||
| Package | B0663110330003 | HIBCC | INNER CARTON | 10 | In Commercial Distribution | |
| Package | B0663110330007 | HIBCC | PARTIAL CASE | 30 | In Commercial Distribution | |
| Package | B0663110330006 | HIBCC | PARTIAL CASE | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-854-0567
- [email protected]