FDA.reportPublic FDA data

BackVive

Primary DI
00850018777469
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

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

Contacts#

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

Regulatory Flags#

DUNS number
007908602
Device count
2
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

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
00850018777025microMendM3S2D001M3S2D0012022-12-08
00850018777049microMend PROMM12XS2MM12XS22022-12-08
00850018777117microMend PROMM12SM4MM12SM42022-12-08
00850018777223microMendM2SXD002M2SXD0022022-12-08
00850018777261microMend MSXWD004MSXWD0042022-12-08
00850018777278microMend PROMM12LG4MM12LG42022-12-08
00850018777292microMend PROMM01SU2MM01SU22022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800109203300Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203317Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203324Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203331Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203348Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203355Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203362Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203379Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203386Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08800109203393Silicone BandageAP MDS Co., Ltd.KGX2024-04-19
08600036236644Brijjit Force Modulating Tissue BridgesBRIJ Medical, Inc.KGX2024-03-01
08428012300468AC-tape PlusFARMABAN SAKGX2023-06-07
08428012300482AC-tape PlusFARMABAN SAKGX2023-06-07
08428012300529AC-tape PlusFARMABAN SAKGX2023-06-07
08428012300536AC-tape PlusFARMABAN SAKGX2023-06-07
08600036236330Brijjit Force Modulating Tissue BridgesBRIJ Medical, Inc.KGX2022-12-02
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27