FDA.reportPublic FDA data

SCIg60 Infusion System

Primary DI
00817708020274
Brand
SCIg60 Infusion System
Company
EMED TECHNOLOGIES CORPORATION
Model
FP-0010002
Catalog number
FP-0010002
Device description
SCIg60 Infuser (Mechanical Pump) Assembly
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKPImmunoglobulin G (Igg) Infusion System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKPImmunoglobulin G (Igg) Infusion SystemGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142319000
K161906000
K173783000
K222087000
K240148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142319000SCIg60 Infuser, InfusetEmed Technologies Corporation2015-05-14PKP
K161906000SCIg60 InfuserEmed Technologies Corporation2016-12-01PKP
K173783000SCIg60 Infusion SystemEmed Technologies Corporation2018-12-14PKP
K222087000SCIg60 Infusion SystemEmed Technologies Corporation2022-10-13PKP
K240148000SCIg60 Infusion SystemEmed Technologies Corporation2024-02-16PKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817708020274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817708020274008177080202748177080202740817708020274

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, mechanical, reusableA non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may be used for patient-controlled analgesia (PCA), and may include mechanical indicators for flow and fluid level status. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(916) 932-0071customerservice@emedtc.com

Regulatory Flags#

DUNS number
622637544
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817708022957Tetra MicroTM-20FP-00102132026-02-24
00817708022971Tetra MicroFP-0010214FP-00102142026-02-24
00817708023374Tetra MicroFP-0010215FP-00102152026-02-24
00817708023428Tetra MicroFP-0010216FP-00102162026-02-24
00817708023435Tetra MicroTM-50FP-00102122026-02-24
00817708023411OPTFlowOPT12609-46Q10OPT12609-46Q102026-01-09
10817708023418OPTFlowOPT12609-46Q10OPT12609-46Q102026-01-09
00817708023381EMED Soluble Hemostatic GauzeEHEM22-10EHEM22-102019-01-30
00817708023398SCIg60FP-00100322020-08-07
10817708020554SAF-QSAF-Q-106-G24-Q10SAF-Q-106-G24-Q102020-12-07
10817708020578SAF-QSAF-Q-106-G27-Q10SAF-Q-106-G27-Q102020-12-07
10817708020615SAF-QSAF-Q-106-SNF-Q10SAF-Q-106-SNF-Q102020-12-07
10817708020639SAF-QSAF-Q-109-G24-Q10SAF-Q-109-G24-Q102020-12-07
10817708020677SAF-QSAF-Q-109-G27-Q10SAF-Q-109-G27-Q102020-12-07
10817708020691SAF-QSAF-Q-109-G27-SNF-Q10SAF-Q-109-G27-SNF-Q102020-12-07
10817708020714SAF-QSAF-Q-112-G24-70-Q10SAF-Q-112-G24-70-Q102020-12-07
10817708020738SAF-QSAF-Q-112-G27-Q10SAF-Q-112-G27-Q102020-12-07
10817708021155SUB-QSUB-104-G27-Q10SUB-104-G27-Q102020-12-07
10817708021179SUB-QSUB-106-G27-Q10SUB-106-G27-Q102020-12-07
10817708021193SUB-QSUB-106-G27-70-Q10SUB-106-G27-70-Q102020-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817708022957Tetra MicroEMED TECHNOLOGIES CORPORATIONPKP2026-02-24
00817708022971Tetra MicroEMED TECHNOLOGIES CORPORATIONPKP2026-02-24
00817708023374Tetra MicroEMED TECHNOLOGIES CORPORATIONPKP2026-02-24
00817708023428Tetra MicroEMED TECHNOLOGIES CORPORATIONPKP2026-02-24
00817708023435Tetra MicroEMED TECHNOLOGIES CORPORATIONPKP2026-02-24
00817708023404VersaPump InfuserEMED TECHNOLOGIES CORPORATIONPKP2023-12-18
00817708023398SCIg60EMED TECHNOLOGIES CORPORATIONPKP2020-08-07
00659443000001FREEDOM60®REPRO MED SYSTEMS, INC.PKP2016-08-19
00659443000018FreedomEdgeTMREPRO MED SYSTEMS, INC.PKP2016-08-19