FDA UDI
In Commercial Distribution
🇺🇸 United States
Equashield
DI: 07290013484628
·
Model: Sampling kit syringe
·
EQUASHIELD MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Equashield
- Primary DI
- 07290013484628
- Version / Model
- Sampling kit syringe
- Catalog Number
- SK-5/2
- Company Name
- EQUASHIELD MEDICAL LTD
- Labeler DUNS
- 533172743
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-24
- Public Version
- 1
- Public Version Date
- 2022-02-01
- Public Version Status
- New
- Public Device Record Key
- 1761e534-69c9-4bf0-af0d-fcfd3a7ef34b
Device Description
The Sampling Kit Syringe is used for general purpose laboratory use. Intended to be used for specific medical use such as collecting a sample from an IV bag and transferring it to laboratory tubes for further testing. The sampling kit syringe is constructed from; EQ syringe (5ml, 35ml, 60ml), Luer lock port and tubing. The Sampling kit syringe is sterile.
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 |
|---|---|---|---|---|
| KJG | Tube, Tissue Culture | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41646 | Compounding transfer set | A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290013484625 | GS1 | BOX | 32 | In Commercial Distribution | |
| Primary | 07290013484628 | GS1 | ||||
| Package | 27290013484622 | GS1 | Case | 64 | In Commercial Distribution |