FDA.reportPublic FDA data

Accu-Chek Rapid-D

Primary DI
04015630046720
Brand
Accu-Chek Rapid-D
Company
Roche Diabetes Care GmbH
Model
04541111001
Catalog number
04541111001
Device description
Accu-Chek Rapid-D 6/110 15+5+5pcs
Published
2016-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630046720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630046720040156300467204015630046720

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
313212471
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04015630088928Accu-Chek Care10095946001100959460012024-11-07
04015630046713Accu-Chek Rapid-D04541103001045411030012016-08-23
04015630048601Accu-Chek Link Assist04530039001045300390012016-08-12
04015630049929Accu-Chek Ultraflex04626583001046265830012016-08-25
04015630049936Accu-Chek Ultraflex04626591001046265910012016-08-25
04015630049943Accu-Chek Ultraflex04626605001046266050012016-08-25
04015630049950Accu-Chek Ultraflex04626613001046266130012016-08-25
04015630049967Accu-Chek Ultraflex04626621001046266210012016-08-25
04015630049974Accu-Chek Ultraflex04626648001046266480012016-08-25
04015630880119Accu-Chek Combo050272500012016-08-25
04015630882755Accu-Chek Spirit Cartridge04949935001049499350012016-08-26
04015630882908Accu-Chek Spirit Cartridge05206073001052060730012016-08-26
04015630883691Accu-Chek Combo05458382001054583820012016-08-25
04015630883806Accu-Chek Combo05458544001054585440012016-08-25
04015630888627Accu-Chek Ultraflex06593976001065939760012016-08-26
04015630888634Accu-Chek Ultraflex06593984001065939840012016-08-26
00075537474198Accu-Chek Compact Plus05599415160055994151602016-08-25
00075537927144Accu-Chek Compact Plus05919983160059199831602016-08-26
00064562213216Accu-Chek Softclix03146693119031466931192023-02-03
00064562213223Accu-Chek Softclix03146707119031467071192023-02-03

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Primary DI, Brand, Company table
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05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
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00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06