FDA UDI
In Commercial Distribution
🇺🇸 United States
Mobility+ Enteral Feeding Device 1900 mm
DI: 05391537090158
·
Model: MOB2-1900
·
ROCKFIELD MEDICAL DEVICES LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- Mobility+ Enteral Feeding Device 1900 mm
- Primary DI
- 05391537090158
- Version / Model
- MOB2-1900
- Catalog Number
- MOB2-1900-30, MOB2-1900-03,MOB2-1900-03-09, MOB2-1900-10, MOB2-1900-10-03
- 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
- 13a06cb6-bbec-4147-b6b7-14008779da0f
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)
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 05391537090196 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 05391537090158 | GS1 | ||||
| Package | 05391537090233 | GS1 | Pack | 3 | In Commercial Distribution | |
| Package | 05391537090271 | GS1 | Case | 9 | In Commercial Distribution | |
| Package | 05391537090318 | GS1 | Pack | 10 | In Commercial Distribution | |
| Package | 05391537090356 | GS1 | Case | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233034 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1900 | Millimeter |