FDA UDI
In Commercial Distribution
🇺🇸 United States
PRIMED
DI: 00842942017247
·
Model: PM4-68394
·
priMED Medical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- PRIMED
- Primary DI
- 00842942017247
- Version / Model
- PM4-68394
- Company Name
- priMED Medical Products Inc
- Labeler DUNS
- 253287569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-07-15
- Public Version
- 1
- Public Version Date
- 2025-07-23
- Public Version Status
- New
- Public Device Record Key
- a6ca4251-d02c-4214-88f9-ce2a2ac7f5a2
Device Description
Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal.
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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65091 | Bone-conduction hearing aid, head-worn | An electrically-powered, external, acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically incorporates a microphone, amplifier, and vibrator mounted or magnetically connected to a head-worn device (e.g., headband or spectacles); it may include positioning and protection devices. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842942017244 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00842942017247 | GS1 | ||||
| Unit of Use | 90842942017240 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight.