BackVive P2B1D001
GUDID 00850018777445
Qty. 2 of BackVive, 3.3 in x 1.4 in (8.4 cm x 3.6 cm)
Kitotech Medical Inc
Acupuncture needle, single-use| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018777445 [Unit of Use] |
| GS1 | 00850018777469 [Primary] |
FDA Product Code
| KGX | Tape And Bandage, Adhesive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-06 |
| Device Publish Date | 2024-04-26 |
Devices Manufactured by Kitotech Medical Inc
| 00850018777025 - microMend | 2024-05-17 Emergency Laceration Closures (Qty. 6), MULTI: 3 Packs of 2 MEDIUM 1/2 IN x 1 IN (12 mm x 28 mm) |
| 00850018777049 - microMend PRO | 2024-05-17 Skin Closure Devices: Small - 7 mm x 28 mm (2 Closures per Pouch) |
| 00850018777117 - microMend PRO | 2024-05-17 Skin Closure Devices: Medium - 12 mm x 28 mm (4 Closures per Pouch) |
| 00850018777223 - microMend | 2024-05-17 Emergency Laceration Closures (Qty. 4), COMBO: 1 Pack of 2 SMALL 1/4 IN x 1 IN (7 mm x 28 mm); 1 Pack of 2 MEDIUM 1/2 IN x 1 IN |
| 00850018777261 - microMend | 2024-05-17 Emergency Laceration Closures (Qty. 5), VARIETY: 1 Pack of 2 SMALL 1/4 IN x 1 IN (7 mm x 28 mm); 1 Pack of 2 MEDIUM 1/2 IN x 1 I |
| 00850018777278 - microMend PRO | 2024-05-17 Skin Closure Devices: Large - 12 mm x 43 mm (4 Closures per Pouch) |
| 00850018777292 - microMend PRO | 2024-05-17 Skin Closure Devices: Umbilical - 12 mm x 26 mm (2 Closures per Pouch) |
| 00850018777001 - microMend PRO | 2024-05-17 Skin Closure Devices: Medium - 12 mm x 28 mm (2 Closures per Pouch) |
Trademark Results [BackVive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BACKVIVE 98467852 not registered Live/Pending |
KitoTech Medical, Inc. 2024-03-26 |
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