FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro Minimuffs
DI: 00628725095318
·
Model: 040342
·
CHS USA Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Micro Minimuffs
- Primary DI
- 00628725095318
- Version / Model
- 040342
- Catalog Number
- 040342
- Company Name
- CHS USA Inc.
- Labeler DUNS
- 118995594
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- 51f51d24-42dc-4872-8d94-16a4e3323f12
Device Description
Minimuffs Neonatal Noise Attenuators
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| EWE | Protector, Hearing (Circumaural) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63512 | Infant acoustic earmuffs | A device consisting of two ear-covering cups (one for each ear) intended to provide noise insulation for neonates/infants in a special care unit. The cups are typically lined with sound attenuating material and held in place by hydrocolloid/hydro gel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50628725095313 | GS1 | 36 | In Commercial Distribution | ||
| Primary | 00628725095318 | GS1 |