FDA.reportPublic FDA data

RPC

Primary DI
20858293006018
Brand
RPC
Company
REPROCESSING PRODUCTS CORPORATION
Model
7001-3926
Catalog number
7001-3926
Device description
Injectable Catheter Cap
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCEAdaptor, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCEAdaptor, CatheterGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K855039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K855039000MEDIFLEX INJECTION CAPMediflex Intl.1986-01-24GCE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858293006011PackageGS1100In Commercial Distribution
20858293006018PackageGS11000In Commercial Distribution
00858293006014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085829300601110858293006011
2085829300601820858293006018
00858293006014008582930060148582930060140858293006014

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter disinfection capA sterile (or with sterile fluid path) cap intended to be placed on one of the alternative connectors in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083392
Device count
1
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
00858293006328EZ-ChekK100-0101BK100-0101B2017-03-07
00858293006915Accu-ReadBP00-22012025-04-02
00858293006120Micro-XK100-0105K100-01052017-03-07
00858293006922Micro-XMX-32122023-02-20
00858293006458Luer Fitting FemaleBF00-00102019-08-30
00858293006465Luer Fitting MaleBF00-00112019-08-30
00858293006496Black Tubing, NaturalBT00-01002019-08-30
00858293006502Black Tubing, PVCBT00-01032019-08-30
00858293006908Spiral Coil Tubing, Trans BluePU532-8TD0PU532-8WT02021-05-17
00858293006373E-Z Chek5116AK100-01172017-03-07
00858293006380EZ-Chek5100AK100-0101B2017-03-07
00858293006885Spiral Coil Tubing, Clear1W-013-102021-05-17
00858293006892Spiral Coil Tubing, Trans RedPU532-8WD02021-05-17
00858293006861Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006878Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006700Spiral Tubing, Trans Red1W-013-252019-08-30
00858293006717Spirial Tubing, Trans Blue1W-013-272019-08-30
00858293006724Spiral Coil Tubing Clear1W-025-102019-08-30
00858293006731Spiral Coil Tubing, Trans Red1W-025-252019-08-30
00858293006748Spiral Coil Tubing, Trans Blue1W-025-272019-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04044503008145FUJIFILM medworkFUJIFILM medwork GmbHGCE2026-03-31
06932503562256Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
16932503562253Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
00850052377007CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054918CLR PortCLR MedicalGCE2024-05-29
00860003054994CLR Port CapCLR MedicalGCE2024-05-29
00850052377021CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054956CLR PortCLR MedicalGCE2024-05-29
00850052377014CLR Port CapCLR MedicalGCE2024-05-29
00887709078017ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00887709078024ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078014ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078021ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00827002226760COOKCOOK INCORPORATEDGCE2022-12-08
00827002226777COOKCOOK INCORPORATEDGCE2022-12-08
M7525250520STRADIS HEALTHCARESTRADIS MEDICAL, LLCGCE2022-03-09
06932503562218Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562225Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562232Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562249Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562263Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562270Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562287Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562294Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562300Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562215MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562222MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562239MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562246MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562260MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31