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
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11