FDA.reportPublic FDA data

ARC Adjustable Radial Cuff

Primary DI
00811331011487
Brand
ARC Adjustable Radial Cuff
Company
Tz Medical, Inc.
Model
RCB-0049
Device description
ARC Adjustable Radial Cuff- Large
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040208000NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BANDTz Medical, Inc.2004-05-11QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811331011487PrimaryGS10
00811331011470Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811331011487008113310114878113310114870811331011487
00811331011470008113310114708113310114700811331011470

GMDN Terms#

Term, Definition table
TermDefinition
Radial artery compression deviceA device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.

Regulatory Flags#

DUNS number
793149709
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811331013610Retractor DistractorDP-72-CDR2025-02-12
00811331013634Retractor DistractorDP-74-CDL2025-02-12
00811331011227EZ HolderCT-00102023-10-20
00811331011340ARC Adjustable Radial CuffRCB-00482023-11-15
00811331011500ARC Adjustable Radial CuffRCB-00472023-11-15
00811331011470ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011333ARC Adjustable Radial CuffRCB-00472023-11-15
00811331013917H3R USB CableH3R-00252023-11-15
00811331013931H3R HolsterH3R-00272023-11-15
10811331010173Comfort BandCB-8514B2023-10-20
10811331010180Comfort BandCB-8517P2023-10-20
10811331010487TZ Medical Pressure Discs8880-042023-10-20
10811331013259TZ Medical Pressure Discs8880-032023-10-20
00811331010053TZ Medical Pressure Discs8880-022023-10-20
00811331011654TruBrite Adhesive Retractor LightARL-10102023-10-20
00811331011722TZ Medical Pressure Discs8880-012023-10-20
00811331011845TZ Medical Pressure Discs8880-062023-10-20
00811331013245TZ Medical Pressure Discs8880-022023-10-20
00811331011210EZ HolderCT-00102023-10-20
00811331011647TruBrite Adhesive Retractor LightARL-10102023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08