FDA.reportPublic FDA data

AccuFlo

Primary DI
00817708020243
Brand
AccuFlo
Company
EMED TECHNOLOGIES CORPORATION
Model
FLO-110
Catalog number
FLO-110
Device description
Fluid Delivery Set
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
FPKTubing, Fluid Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935642000EVANS MEDICAL EXTENSION SETSEvans Medical, Inc.1994-01-28FPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817708020243PrimaryGS10
00817708020236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817708020243008177080202438177080202430817708020243
00817708020236008177080202368177080202360817708020236

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use 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
50
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
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
10884450628307Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
10192253003338MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003345MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003352MonojectCardinal Health 200, LLCFPK2024-08-21
00616258024554Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
00616258024561MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
00616258024820MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450325312Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2021-04-05
00849884005141VYGONVygon CorporationFPK2021-01-28
10849884002260VYGONVygon CorporationFPK2020-06-02
00849884002720VYGONVygon CorporationFPK2020-06-01
0063462495724425ft/7.6m IV Extension Set QUEST MEDICAL INCFPK2020-04-13
10849884002666VYGONVygon CorporationFPK2020-04-02
10849884002765VYGONVygon CorporationFPK2020-04-02
10849884002581VYGONVygon CorporationFPK2020-04-01
00849884004441VYGONVygon CorporationFPK2020-03-12
00849884003956VYGONVygon CorporationFPK2020-01-28
00849884004007VYGONVygon CorporationFPK2020-01-28
10351688507112MedexICU MEDICAL, INC.FPK2020-01-13
00849884000320VYGONVygon CorporationFPK2019-12-16
00849884000559VYGONVygon CorporationFPK2019-12-16
00849884000566VYGONVygon CorporationFPK2019-12-16
00634624957817Exoflex 10.5in. IVExtension Set QUEST MEDICAL INCFPK2019-12-09
00849884000269VYGONVygon CorporationFPK2019-11-14
00849884000313VYGONVygon CorporationFPK2019-11-14
00849884000375VYGONVygon CorporationFPK2019-11-14
00849884000443VYGONVygon CorporationFPK2019-11-14
00849884000450VYGONVygon CorporationFPK2019-11-14
00849884000467VYGONVygon CorporationFPK2019-11-14
00849884000535VYGONVygon CorporationFPK2019-11-14