FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Medical Action Industries
DI: 10809160021675
·
Model: 80391
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Action Industries
- Primary DI
- 10809160021675
- Version / Model
- 80391
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 3
- Public Version Date
- 2021-03-03
- Public Version Status
- Update
- Public Device Record Key
- 39a951c3-ec93-41ed-b1c8-23f3d2c14ee0
- Distribution End Date
- 2021-03-02
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHR | Catheter care tray | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47777 | Intermittent urethral catheterization kit, non-sterile | A collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. Because of the potential frequency of catheterization, the catheter will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFE) commonly known as Teflon, or glass], and possibly coated with an antibiotic to help prevent infection of the urinary tract. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160021672 | GS1 | 8 | Not in Commercial Distribution | 2021-03-02 | |
| Primary | 10809160021675 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature
- Type
- Special Storage Condition, Specify