FDA.reportPublic FDA data

DiamondTemp™ Irrigation Pump

Primary DI
00763000709051
Brand
DiamondTemp™ Irrigation Pump
Company
MEDTRONIC, INC.
Model
CEDTP100
Device description
IRRIGATION PUMP CEDTP100 US
Published
2024-12-13
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
P200028021

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200028021DiamondTemp Ablation SystemMedtronic, Inc.2021-01-28OAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000709051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000709051007630007090517630007090510763000709051

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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067054661TactiSys™ST. JUDE MEDICAL, INC.OAE2026-08-19
00763000954345NAMEDTRONIC, INC.OAE2026-08-14
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