FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632100543
·
Model: PG4-1573
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
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Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632100543
- Version / Model
- PG4-1573
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 5
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 148b2fef-6e84-48d0-8c29-175ad13496da
Device Description
Mask Procedure Face PRIMAGARD160 Anti-Fog Foam Anti Glare Strip Stretchy Earloop With Anti Glare Visor Foam Strip Aluminum Nose Piece Indigo Disposable Not Made With Natural Rubber Latex MediChoice
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXX | Mask, surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58376 | Eye splash shield, single-use | A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632100541 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 10885632100543 | GS1 | ||||
| Unit of Use | 60885632100548 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight
- Type
- Special Storage Condition, Specify