FDA UDI
In Commercial Distribution
🇺🇸 United States
Munchkin
DI: 00735282286810
·
Model: MKFE0964 Rev 1
·
MUNCHKIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Munchkin
- Primary DI
- 00735282286810
- Version / Model
- MKFE0964 Rev 1
- Catalog Number
- 28681
- Company Name
- MUNCHKIN, INC.
- Labeler DUNS
- 787026855
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-12
- Public Version
- 1
- Public Version Date
- 2025-02-20
- Public Version Status
- New
- Public Device Record Key
- 361c873e-628a-42bd-80a4-6d5221ac5af7
Device Description
2 Silver Nursing Cups | 1 Storage Bag
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HFS | Shield, Nipple | General Hospital | 880.5630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43272 | Nipple pad/ring, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10735282286817 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00735282286810 | GS1 |
Customer Contacts
- Phone
- 818 293-5000
- [email protected]