FDA UDI
In Commercial Distribution
🇺🇸 United States
AVID TRUCUSTOM
DI: 10809160109960
·
Model: VMED004-02
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVID TRUCUSTOM
- Primary DI
- 10809160109960
- Version / Model
- VMED004-02
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-12
- Public Version
- 3
- Public Version Date
- 2019-01-23
- Public Version Status
- Update
- Public Device Record Key
- f09a5579-c8a0-429d-8214-9169f950f33e
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FKG | TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS | Gastroenterology, Urology | 876.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32142 | Haemodialysis start/stop set | A collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160109967 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10809160109960 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE AT ROOM TEMPERATURE