FDA.reportPublic FDA data

BackVive

Primary DI
00850018777445
Brand
BackVive
Company
Kitotech Medical Inc
Model
P2B1D001
Catalog number
P2B1D001
Device description
Qty. 2 of BackVive, 3.3 in x 1.4 in (8.4 cm x 3.6 cm)
Published
2024-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018777469PrimaryGS10
00850018777445Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018777469008500187774698500187774690850018777469
00850018777445008500187774458500187774450850018777445

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius26 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877) 420-1502customerservice@kitotechmedical.com

Regulatory Flags#

DUNS number
007908602
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018777087microMend PROMM12SM2MM12SM22022-12-08
00850018777100microMend PROMM12LG2MM12LG22022-12-08
00850018777124microMend PROMM12SM4MM12SM42022-12-08
00850018777162microMend PROMM12W2SMM12W2S2022-12-08
00850018777186microMend PROMM12W2AMM12W2A2022-12-08
00850018777285microMend PROMM12LG4MM12LG42022-12-08
00850018777308microMend PROMM12SU2MM12SU22022-12-08
00850018777315microMend PROMM01SU2MM01SU22022-12-08
00850018777322microMend PROMM01SM2MM01SM22022-12-08
00850018777339microMend PROMM01XS2MM01XS22022-12-08
00850018777346microMend PROMM01LG2MM01LG22022-12-08
00850018777360microMend PROMM01W2SMM01W2S2022-12-08
00850018777391microMend PROMM01W2AMM01W2A2022-12-08
00850018777469BackViveP2B1D001P2B1D0012024-04-26
00850018777025microMendM3S2D001M3S2D0012022-12-08
00850018777049microMend PROMM12XS2MM12XS22022-12-08
00850018777117microMend PROMM12SM4MM12SM42022-12-08
00850018777223microMendM2SXD002M2SXD0022022-12-08
00850018777261microMend MSXWD004MSXWD0042022-12-08
00850018777278microMend PROMM12LG4MM12LG42022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08