FDA UDI
In Commercial Distribution
🇺🇸 United States
Tube Organiser
DI: 05051223004424
·
Model: PS5100
·
PURPLE SURGICAL INTERNATIONAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tube Organiser
- Primary DI
- 05051223004424
- Version / Model
- PS5100
- Catalog Number
- PS5100
- Company Name
- PURPLE SURGICAL INTERNATIONAL LIMITED
- Labeler DUNS
- 239403863
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 57f7ce63-457c-4ab8-88e6-9901c6ae9dd9
Device Description
The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion.
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56630 | Universal patient tubing holder, sterile | A small, sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 55051223004429 | GS1 | shipping carton | 100 | In Commercial Distribution | |
| Package | 35051223004425 | GS1 | shelf box | 25 | In Commercial Distribution | |
| Primary | 05051223004424 | GS1 |
Customer Contacts
- Phone
- +441923839333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 110mm length x 15mm width |