Primary Device ID | 00850018777445 |
NIH Device Record Key | 3150ac23-ac48-4065-880f-d144394e906e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BackVive |
Version Model Number | P2B1D001 |
Catalog Number | P2B1D001 |
Company DUNS | 007908602 |
Company Name | Kitotech Medical Inc |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com | |
Phone | (877) 420-1502 |
customerservice@kitotechmedical.com |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Storage Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850018777445 [Unit of Use] |
GS1 | 00850018777469 [Primary] |
KGX | Tape And Bandage, Adhesive |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-06 |
Device Publish Date | 2024-04-26 |
00850018777445 - BackVive | 2024-05-06Qty. 2 of BackVive, 3.3 in x 1.4 in (8.4 cm x 3.6 cm) |
00850018777445 - BackVive | 2024-05-06 Qty. 2 of BackVive, 3.3 in x 1.4 in (8.4 cm x 3.6 cm) |
00850018777247 - microMend | 2023-09-26 Emergency Laceration Kit: 2 – microMend Closures 1/2 IN x 1 IN (12 mm x 28 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x 17 |
00850018777018 - microMend | 2023-09-25 Emergency Laceration Kit: 2 – microMend Closures 1/2 IN x 1 IN (12 mm x 28 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x 17 |
00850018777414 - microMend | 2023-09-25 Wound Closure Kit: 2 – microMend LARGE Closures 1/2 IN x 1 3/4 IN (12 mm x 43 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (127 mm x |
00850018777421 - microMend | 2023-03-08 2-in-1 Wound Repair Kit: 2 – microMend LARGE Closures 1/2 IN x 1 3/4 IN (12 mm x 43 mm); 1 – Antiseptic Wipe 5 IN x 7 IN (12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BACKVIVE 98467852 not registered Live/Pending |
KitoTech Medical, Inc. 2024-03-26 |