FDA UDI
In Commercial Distribution
🇺🇸 United States
Westcliff Medical Products
DI: 00862572000358
·
Model: WC6018
·
WESTCLIFF MEDICAL PRODUCTS
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Westcliff Medical Products
- Primary DI
- 00862572000358
- Version / Model
- WC6018
- Company Name
- WESTCLIFF MEDICAL PRODUCTS
- Labeler DUNS
- 067695404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-17
- Public Version
- 1
- Public Version Date
- 2019-05-27
- Public Version Status
- New
- Public Device Record Key
- 29294564-fcc6-479a-8462-d64d9b2b2dbf
- Distribution End Date
- 2099-05-07
Device Description
Blood Transfer 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
- Yes
- 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 |
|---|---|---|---|---|
| KST | System, Blood Collection, Vacuum-Assisted, Manual | Hematology | 864.9125 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862572000358 | GS1 | ||||
| Package | 10862572000355 | GS1 | Box | 200 | In Commercial Distribution | 2099-05-07 |
| Package | 20862572000352 | GS1 | Case | 800 | In Commercial Distribution | 2099-05-07 |