FDA UDI
In Commercial Distribution
🇺🇸 United States
Medegen Medical Products
DI: 00700812001232
·
Model: H141-01
·
MEDEGEN MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Medegen Medical Products
- Primary DI
- 00700812001232
- Version / Model
- H141-01
- Catalog Number
- H141-01
- Company Name
- MEDEGEN MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 055527753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-05-18
- Public Version
- 2
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 46d42e4d-e2c6-4ca0-974f-b0a74f712b46
Device Description
Urinal wTransCvr Bagged 50/cs 18/plt
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FNP | Urinal | General Hospital | 880.6730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40955 | Hand-held urinal, single-use | A portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10700812001239 | GS1 | ||||
| Primary | 00700812001232 | GS1 |
Customer Contacts
- Phone
- 901-867-4230
- [email protected]