FDA.reportPublic FDA data

Zephyr®

Primary DI
H758582007
Brand
Zephyr®
Company
ST. JUDE MEDICAL, INC.
Model
DR
Catalog number
5820
Published
2014-10-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880086139

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880086139ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734501613PrimaryGS10
H758582007SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734501613054147345016135414734501613

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable pacemaker, rate-responsiveA sterile, battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812058NAMEDTRONIC, INC.NVZ2025-04-12
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NVZ2024-11-13
00763000378356Instrument Command LibraryMEDTRONIC, INC.NVZ2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.NVZ2024-05-04
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000612665MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000688400CareLink SmartSync™MEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NVZ2022-10-28
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000181345NAMEDTRONIC, INC.NVZ2021-06-12
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2021-02-25
00763000414023MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414030MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414047MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316723Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316730Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.NVZ2020-11-28
00763000316761Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316778Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316785Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316792Adapta™MEDTRONIC, INC.NVZ2020-11-28