FDA UDI
In Commercial Distribution
🇺🇸 United States
Avaline Medical NJ LLC
DI: 00810077213117
·
Model: vk5cbp
·
Avaline Medical NJ Limited Liability Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Avaline Medical NJ LLC
- Primary DI
- 00810077213117
- Version / Model
- vk5cbp
- Catalog Number
- vk5cbp
- Company Name
- Avaline Medical NJ Limited Liability Company
- Labeler DUNS
- 079767953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-03-05
- Public Version
- 1
- Public Version Date
- 2022-03-14
- Public Version Status
- New
- Public Device Record Key
- d9bf7ac6-8ede-4486-96d8-1c3e5f09ee53
Device Description
Stackable Contour Bedpansx5
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 34867 | Bedpan | A portable device used by a patient or a person with a disability that is confined to his/her bed as a receptacle in which to urinate and/or defecate. It will be removed and emptied by attending staff and sanitized for reuse. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810077213209 | GS1 | ||||
| Primary | 00810077213117 | GS1 |
Customer Contacts
- Phone
- +1(732)813-7799 ext. 204
- [email protected]