Primary Device ID | D687203242 |
NIH Device Record Key | 9c89aa65-c5b2-466c-98c6-824e6fc6f284 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Com-Fit® |
Version Model Number | 20324 |
Company DUNS | 056296981 |
Company Name | Sultan Healthcare Inc |
Device Count | 50 |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)989-8825 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D687203240 [Unit of Use] |
HIBCC | D687203241 [Primary] |
HIBCC | D687203242 [Package] Contains: D687203241 Package: Case [10 Units] In Commercial Distribution |
FXX | Mask, surgical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-05-06 |
Device Publish Date | 2016-09-23 |
D687203572 | Com-Fit Plush™ Natural Fit Masks ASTM #3 Box of 40 |
D687203562 | Com-Fit Plush™ Natural Fit Masks ASTM #2 Box of 40 |
D687203552 | Com-Fit Plush™ Natural Fit Masks ASTM #1 Box of 40 |
D687203542 | com-fit Plush™ Masks CFP-3 Earloop Box of 40 |
D687203532 | com-fit Plush™ Masks CFP-2 Earloop Box of 40 |
D687203522 | com-fit Plush™ Masks CFP-1 Earloop Box of 40 |
D687203502 | Groovy Mask com-fit® mask Earloop Box of 40 |
D687203462 | Super Sensitive com-fit® mask Earloop Box of 50 |
D687203442 | Super Sensitive com-fit® mask Tie-On Box of 50 |
D687203422 | Easy Breathe™ com-fit® mask Tie-On Box of 40 |
D687203402 | Easy Breathe™ com-fit® mask Earloop Box of 40 |
D687203362 | Super High Filtration com-fit® mask Tie-On Box of 40 |
D687203282 | Super High Filtration with eyeshield com-fit® Earloop Box of 25 |
D687203262 | Super High Filtration com-fit® mask Earloop Box of 40 |
D687203252 | Fluid Resistant Procedural Pink com-fit® mask Box of 50 |
D687203242 | Fluid Resistant Procedural Blue com-fit® mask Box of 50 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COM-FIT 77806095 4389935 Live/Registered |
DENTSPLY SIRONA INC. 2009-08-17 |
COM-FIT 77627514 not registered Dead/Abandoned |
Protective Products Holdings, Inc. 2008-12-05 |
COM-FIT 75313675 2193481 Dead/Cancelled |
P.H. Seven, Inc. 1997-06-24 |
COM-FIT 73791332 1643547 Dead/Cancelled |
NORMAN M. MORRIS CORPORATION 1989-04-05 |
COM-FIT 73784112 not registered Dead/Abandoned |
SULTAN CHEMISTS, INC. 1989-03-02 |
COM-FIT 72266261 0845539 Dead/Expired |
SIGMA SALES CORP. OF CALIFORNIA 1967-03-08 |