FDA UDI
In Commercial Distribution
🇺🇸 United States
FRESENIUS KABI
DI: 10813153027629
·
Model: FK30100KG
·
Codan US Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FRESENIUS KABI
- Primary DI
- 10813153027629
- Version / Model
- FK30100KG
- Company Name
- Codan US Corporation
- Labeler DUNS
- 058027475
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-03
- Public Version
- 1
- Public Version Date
- 2024-10-11
- Public Version Status
- New
- Public Device Record Key
- 3fc69d05-234e-4169-a2d5-3495b62614a3
Device Description
GRAVITY SET
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58974 | Enteral feeding/decompression tube clearing stem | A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. It consists of a sheath and a stem clog disrupter (e.g., a wire or rod) designed to be magnetically coupled with a motorized actuator which facilitates the forward and backward movement of the disrupter inside the sheath. It typically has a collar to restrict the inserted length, and a diameter, appropriate for the installed feeding/decompression tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10813153027629 | GS1 | ||||
| Package | 00813153027622 | GS1 | MULTIVAC PACKAGING | 1 | In Commercial Distribution |