PRECISION ECO™ Plant Based Procedural Mask with Earloops CS001
GUDID 37540162170219
PRECISION ECO™ Plant Based Procedural Masks with Earloops (LVL 3), B&W Sample [4/PK]
Precision Adm Medical Inc.
Surgical/medical face mask, non-antimicrobial, single-use| Primary Device ID | 37540162170219 |
| NIH Device Record Key | ed0e1779-720e-4f32-a686-961047269b4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRECISION ECO™ Plant Based Procedural Mask with Earloops |
| Version Model Number | CS001 |
| Catalog Number | CS001 |
| Company DUNS | 243265917 |
| Company Name | Precision Adm Medical Inc. |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com | |
| Phone | +1 855 500 7236 |
| info@padmmedical.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540162170218 [Primary] |
| GS1 | 17540162170215 [Package] Contains: 07540162170218 Package: Carton [150 Units] In Commercial Distribution |
| GS1 | 37540162170219 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221209
FDA Product Code
| FXX | Mask, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-08 |
| Device Publish Date | 2023-07-31 |
On-Brand Devices [PRECISION ECO™ Plant Based Procedural Mask with Earloops]
| 17540162170208 | PRECISION ECO™ Plant Based Procedural Mask with Earloops (LVL 3), White [50/BX] |
| 07540162170195 | PRECISION ECO™ Plant Based Procedural Mask with Earloops (LVL 3), Black [50/BX] |
| 37540162170219 | PRECISION ECO™ Plant Based Procedural Masks with Earloops (LVL 3), B&W Sample [4/PK] |
Trademark Results [PRECISION ECO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRECISION ECO 97205023 not registered Live/Pending |
Precision ADM Inc. 2022-01-06 |
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