FDA UDI
In Commercial Distribution
🇺🇸 United States
PRIMED
DI: 00842942017223
·
Model: PM4-68374
·
priMED Medical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- PRIMED
- Primary DI
- 00842942017223
- Version / Model
- PM4-68374
- 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
- ac4aceb5-5b2d-466e-97fc-9682d5f5c6e7
Device Description
Overhead AAMI 4 Open Back Gown, Thumbloop, 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 |
|---|---|---|---|---|
| 35091 | Surgical gown, single-use | A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842942017220 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00842942017223 | GS1 | ||||
| Unit of Use | 90842942017226 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight.