FDA UDI
In Commercial Distribution
🇺🇸 United States
Mobility+ Enteral Feeding Device 440 mm
DI: 05391537090004
·
Model: MOB1-440
·
ROCKFIELD MEDICAL DEVICES LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mobility+ Enteral Feeding Device 440 mm
- Primary DI
- 05391537090004
- Version / Model
- MOB1-440
- Company Name
- ROCKFIELD MEDICAL DEVICES LIMITED
- Labeler DUNS
- 985605545
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-16
- Public Version
- 1
- Public Version Date
- 2023-02-24
- Public Version Status
- New
- Public Device Record Key
- 1a6c24f9-71ec-4c7a-95ab-e6d108117fdb
Device Description
The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver commercially available liquid nutrition formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in the clinical or home care settings.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64461 | Enteral feeding noninvasive-component set | A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391537090004 | GS1 | ||||
| Package | 05391537090042 | GS1 | Standard box | 30 | In Commercial Distribution |
Customer Contacts
- Phone
- 5104210756
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222678 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 440 | Millimeter |