FDA.reportPublic FDA data

DiamondTemp™ Irrigation Pump

Primary DI
00763000540616
Brand
DiamondTemp™ Irrigation Pump
Company
MEDTRONIC, INC.
Model
CEDTP100
Device description
IRRIGATION PUMP CEDTP100 US/CAN
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200028009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200028009DiamondTemp Ablation SystemMedtronic, Inc.2021-01-28OAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000540616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000540616007630005406167630005406160763000540616

GMDN Terms#

Term, Definition table
TermDefinition
Basic roller pumpA mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not stack more than 2 high
Special Storage Condition, Specify00Keep Dry

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-08
05415067051943N/AST. JUDE MEDICAL, INC.OAE2025-10-31
05415067051950TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067051998TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052018TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052025TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052056TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052063TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052216TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052223TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAE2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAE2025-08-30
00763000995003N/AMEDTRONIC, INC.OAE2025-04-12
20763000954363N/AMEDTRONIC, INC.OAE2025-02-22
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAE2025-01-13
00763000708917DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.OAE2024-12-14