FDA UDI
In Commercial Distribution
🇺🇸 United States
Equashield
DI: 07290013484574
·
Model: Equashield Spike Adaptor 180
·
EQUASHIELD MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- Equashield
- Primary DI
- 07290013484574
- Version / Model
- Equashield Spike Adaptor 180
- Company Name
- EQUASHIELD MEDICAL LTD
- Labeler DUNS
- 533172743
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-20
- Public Version
- 2
- Public Version Date
- 2024-06-07
- Public Version Status
- Update
- Public Device Record Key
- 9a9b2998-4742-4df5-8e20-6a91936100c1
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
- 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 |
|---|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41222 | Medication transfer set | A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290013484571 | GS1 | 120 | In Commercial Distribution | ||
| Primary | 07290013484574 | GS1 | ||||
| Package | 27290013484578 | GS1 | 240 | In Commercial Distribution | ||
| Package | 47290013484596 | GS1 | Box | 50 | In Commercial Distribution | |
| Package | 57290013484579 | GS1 | Case | 200 | In Commercial Distribution |