FDA.reportPublic FDA data

NA

Primary DI
00885074244242
Brand
NA
Company
MEDTRONIC, INC.
Model
3554
Device description
ACCESSORY 3554IU 4PK SCREENING BELT EP
Published
2015-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAGGarment, storage, peritoneal dialysis catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAGGarment, Storage, Peritoneal Dialysis CatheterPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074244242PrimaryGS10
70885074244241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074244242008850742442428850742442420885074244242
7088507424424170885074244241

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
4
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715190205Roo DefenderRoo Healthcare Solutions, LLCOAG2026-05-05
00198715680164Roo DefenderRoo Healthcare Solutions, LLCOAG2026-05-05
05391537090080Mobility+ Enteral Feeding Device Bag PurpleROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
05391537090097Mobility+ Enteral Feeding Device Bag BlackROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
05391537090103Mobility+ Enteral Feeding Device Bag PurpleROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
05391537090110Mobility+ Enteral Feeding Device Bag BlackROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
00613994558572NAMEDTRONIC, INC.OAG2015-12-02
00613994558589NAMEDTRONIC, INC.OAG2015-12-02