FDA UDI
In Commercial Distribution
🇺🇸 United States
PRIMED
DI: 00842942013928
·
Model: PM4-67364
·
priMED Medical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- PRIMED
- Primary DI
- 00842942013928
- Version / Model
- PM4-67364
- Company Name
- priMED Medical Products Inc
- Labeler DUNS
- 253287569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-07-21
- Public Version
- 1
- Public Version Date
- 2025-07-29
- Public Version Status
- New
- Public Device Record Key
- 8e9b85fc-e6f5-4bcb-bd55-bca9a3bb2b6b
Device Description
Overhead Cover Gown / Thumbloop with Elastic Cuff / Open Back / Universal / Yellow
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FME | Gown, Examination | General Hospital | 880.6265 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32170 | Professional examination gown, single-use | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842942013925 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00842942013928 | GS1 | ||||
| Unit of Use | 90842942013921 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight.