FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSTOMED
DI: M20890022151
·
Model: 712057462215
·
CUSTOMED INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CUSTOMED
- Primary DI
- M20890022151
- Version / Model
- 712057462215
- Catalog Number
- 9002215
- Company Name
- CUSTOMED INC
- Labeler DUNS
- 627572217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- f2a0a266-45b3-4eeb-af70-c3495933dc11
Device Description
PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR LOOPS, 160MM HG
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 |
|---|---|---|---|---|
| 35177 | Surgical/medical face mask, single-use | A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M20890022151 | HIBCC | ||||
| Unit of Use | M20890022150 | HIBCC | ||||
| Package | M20890022152 | HIBCC | 25/BOX, 4BOX/CS | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 787-622-5151
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081633 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | LEVEL 3 BARRIER PROTECTION 160 MM HG |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Open box should be shielded from exprosure to direct sunlight, intense artificial light, x-ray machines and other sources of ozone.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.