FDA UDI
In Commercial Distribution
🇺🇸 United States
Mobility+ Enteral Feeding Device Bag Purple
DI: 05391537090080
·
Model: PN2001-01
·
ROCKFIELD MEDICAL DEVICES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mobility+ Enteral Feeding Device Bag Purple
- Primary DI
- 05391537090080
- Version / Model
- PN2001-01
- Company Name
- ROCKFIELD MEDICAL DEVICES LIMITED
- Labeler DUNS
- 985605545
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-03
- Public Version
- 1
- Public Version Date
- 2024-07-11
- Public Version Status
- New
- Public Device Record Key
- 02b69e08-a9e7-4d61-9ccb-30af86e10eb8
Device Description
Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Enteral Feeding Device to be worn on the body in a number of configurations.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12500 | Medical bag | A portable, durable, hand-held container of plastic, fabric, or leather designed for transportation of small medical devices, instruments, and/or supplies. It typically includes attachments for easy handling and mechanisms for closure and/or locking; it may have the internal space appropriately configured according to the intended contents (e.g., stethoscopes, sphygmomanometers, drugs). It may be dedicated for a variety of purposes and/or users, including specialization for physicians, nurses, first aid providers, or paramedics. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391537090103 | GS1 | Case | 9 | In Commercial Distribution | |
| Primary | 05391537090080 | GS1 |