FDA.reportPublic FDA data

NA

Primary DI
00613994558572
Brand
NA
Company
MEDTRONIC, INC.
Model
3550-54
Device description
ACCY 3550-54 RECHARGE BELT WAIST
Published
2015-12-02
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
00613994558572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994558572006139945585726139945585720613994558572

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
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

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
00613994558589NAMEDTRONIC, INC.OAG2015-12-02
00885074244242NAMEDTRONIC, INC.OAG2015-11-18