FDA UDI
In Commercial Distribution
🇺🇸 United States
Ameda ComfortGel Hydrogel Pads
DI: 04719745091568
·
Model: 17261M
·
BENQ MATERIALS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Ameda ComfortGel Hydrogel Pads
- Primary DI
- 04719745091568
- Version / Model
- 17261M
- Company Name
- BENQ MATERIALS CORP.
- Labeler DUNS
- 657476292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-01-21
- Public Version
- 1
- Public Version Date
- 2025-01-29
- Public Version Status
- New
- Public Device Record Key
- 0f97cb92-15b7-4344-9708-5e46e22dcdcf
Device Description
Soothes, cools and helps with tender sore nipples. Immediate relief on contact
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NTC | Nursing Pad, Hydrogel | General Hospital | 880.5630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10484 | Nipple pad/ring, single-use | A device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719745091568 | GS1 | ||||
| Unit of Use | 14719745091565 | GS1 |