FDA.reportPublic FDA data

ARC Adjustable Radial Cuff

Primary DI
00811331011470
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793149709
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00811331011487ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011500ARC Adjustable Radial CuffRCB-00472023-11-15
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

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00850087488723CeeportCEEPORT INC.FRO2026-08-26
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00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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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