FDA.reportPublic FDA data

ThermaCor 1200 Infusion System

Primary DI
00857893006080
Brand
ThermaCor 1200 Infusion System
Company
SMISSON-CARTLEDGE BIOMEDICAL, LLC
Model
DC-1200
Device description
Cassette
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular
FRNPump, infusion
LGZWarmer, thermal, infusion fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
FRNPump, InfusionGeneral Hospital2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052055000
K202461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052055000SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200Smisson-Cartledge Biomedical, LLC2006-10-26LGZ
K202461000ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC2022-08-12LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857893006080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857893006080008578930060808578930060800857893006080

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerA mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(478)330-6206donna@t3med.com
+1(478)330-6205donna@t3med.com

Regulatory Flags#

DUNS number
087687179
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857893006066ThermaCor 1200 Infusion SystemPNC-12002016-07-15
00857893006073ThermaCor 1200 Infusion SystemDNC-12002016-07-15
00857893006097ThermaCor 1200 Infusion SystemDL-12002016-07-15
00857893006103ThermaCor 1200 Infusion SystemPL-12002016-07-15
00857893006110ThermaCor 1200 Infusion SystemTSS-12002016-07-15
00857893006127ThermaCor 1200 Infusion SystemEL-12002016-07-15
00857893006059ThermaCor 1200 Infusion SystemPTC-12002016-07-15
00857893006158ThermaCor 1200 Infusion SystemTD-12002016-07-15
00857893006226ThermaCor 1200 Infusion SystemRCAU-12002019-11-25
00857893006004ThermaCor 1200 Infusion SystemTIS-12002016-07-15
00857893006011ThermaCor 1200 Infusion SystemCG-12002016-07-15
00857893006028ThermaCor 1200 Infusion SystemFS-12002016-07-15
00857893006035ThermaCor 1200 Infusion SystemSP-12002016-07-15
00857893006042ThermaCor 1200 Infusion SystemRC-12002016-07-15
00857893006134ThermaCor 1200 Infusion SystemMR-12002016-07-15
00857893006141ThermaCor 1200 Infusion SystemMH-12002016-07-15
00857893006189ThermaCor 1200 Infusion SystemRCB-12002016-09-21
00857893006196ThermaCor 1200 Infusion SystemTH-12002017-05-03
00857893006219ThermaCor 1200 Infusion SystemRCE-12002018-06-19
10857893006056ThermaCor 1200 Infusion SystemPTC-12002016-07-15

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