VersaPump Infuser

Primary DI
00817708023404
Brand
VersaPump Infuser
Company
EMED TECHNOLOGIES CORPORATION
Model
FP-0010209
Catalog number
FP-0010209
Device description
The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).
Published
2023-12-18
Public version status
New
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
K230883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230883000VersaPump Infusion SystemEmed Technologies Corporation2023-11-28PKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817708023404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817708023404008177080234048177080234040817708023404

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory non-insulin 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 patient-controlled analgesia (PCA) 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 include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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

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
00817708020274SCIg60 Infusion SystemFP-0010002FP-00100022016-09-23
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

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
00817708023398SCIg60EMED TECHNOLOGIES CORPORATIONPKP2020-08-07
00817708020274SCIg60 Infusion SystemEMED TECHNOLOGIES CORPORATIONPKP2016-09-23
00659443000001FREEDOM60®REPRO MED SYSTEMS, INC.PKP2016-08-19
00659443000018FreedomEdgeTMREPRO MED SYSTEMS, INC.PKP2016-08-19