FDA UDI
In Commercial Distribution
🇺🇸 United States
Button Huggie
DI: G736110210110
·
Model: Version 1 for AMT MiniONE G-Button
·
EZALIFE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Button Huggie
- Primary DI
- G736110210110
- Version / Model
- Version 1 for AMT MiniONE G-Button
- Catalog Number
- 11021011
- Company Name
- EZALIFE LLC
- Labeler DUNS
- 112861710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-14
- Public Version
- 3
- Public Version Date
- 2026-01-19
- Public Version Status
- Update
- Public Device Record Key
- 99a17b76-ff9c-4221-912e-8b07a3ca9529
Device Description
Button Huggie 1-month supply. The Button Huggie is a G-button securement device composed of a reusable lid (Part “A”) and a disposable base (Part “B”), which sticks to the skin. The disposable base has an inner structure that secures the G-button. A gauze pad may be slid underneath the inner structure to absorb leakage from the gastrostomy. The washable, reusable lid further secures the G-button.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PLI | Gastrointestional Tube Holder | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67665 | Wearable percutaneous catheter/tube holder, reusable | A device designed to fix/stabilize a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended to protect the catheter/tube access point from impact (e.g., knocks, friction). It is a semi-rigid polymer housing with a lid intended to shield the catheter access site, and typically includes a disposable self-adhesive base plate. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G736110210110 | HIBCC |