Primary Device ID | 10850021617001 |
NIH Device Record Key | f58400f6-3e09-4511-8075-4f0036d5e53f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BRS Level 1 Procedure Face Mask with Ear Loops |
Version Model Number | 850021617004 |
Company DUNS | 117425172 |
Company Name | Blackbriar Regulatory Services, LLC |
Device Count | 1 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850021617004 [Primary] |
GS1 | 10850021617001 [Package] Contains: 00850021617004 Package: Case [12 Units] In Commercial Distribution |
FXX | Mask, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-06 |
Device Publish Date | 2021-03-29 |
10850021617193 - BRS Level 2 Procedure Mask with Ear Loops | 2021-04-12 Level 2 Procedure Face Mask with Ear Loops |
00850021617578 - BRS Level 3 Procedure Face Mask - 3 Layers | 2021-04-12 Level 3 Procedure Face Mask with Ear Loops - 3 Layers |
10850021617001 - BRS Level 1 Procedure Face Mask with Ear Loops | 2021-04-06Level 1 Procedure Face Mask with Ear Loops - Updated |
10850021617001 - BRS Level 1 Procedure Face Mask with Ear Loops | 2021-04-06 Level 1 Procedure Face Mask with Ear Loops - Updated |