FDA.reportPublic FDA data

NA

Primary DI
00613994558589
Brand
NA
Company
MEDTRONIC, INC.
Model
3550-55
Device description
ACCY 3550-55 RECHARGE HOLSTER PECTORAL
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
00613994558589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994558589006139945585896139945585890613994558589

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
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

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
00885074244242NAMEDTRONIC, INC.OAG2015-11-18