FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxyless
DI: 05060493650002
·
Model: CK84/14-F
·
OXYLESS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Oxyless
- Primary DI
- 05060493650002
- Version / Model
- CK84/14-F
- Company Name
- OXYLESS LIMITED
- Labeler DUNS
- 218635156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-24
- Public Version
- 4
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- e3aae127-4699-4242-bcfd-0ddce3320c1f
Device Description
The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis.
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
- 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 |
|---|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34999 | Haemodialysis blood tubing set, single-use | A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15060493650009 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 05060493650002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150304 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 146 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 34 – 140 Degrees Fahrenheit