FDA.reportPublic FDA data

Nfuze

Primary DI
16972620111064
Brand
Nfuze
Company
BQ PLUS MEDICAL CO., LTD.
Model
PCS303
Published
2022-05-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210381000I.V. Administration SetBq Plus Medical Co., Ltd.2021-08-14FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972620111064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697262011106416972620111064

GMDN Terms#

Term, Definition table
TermDefinition
Infusion controller administration setA collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544463583
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850067227110NEW PENTASTAR MEDICAL12762026-03-30
00369771001303Gerimedix112212026-03-30
00369771001310Gerimedix112212026-03-30
00810110920972IMSIM420312026-03-30
00850067227113NEW PENTASTAR MEDICAL12762026-03-30
00853155008045IMSIM410002026-03-30
00853155008052IMSIM410012026-03-30
00853155008069IMSIM410022026-03-30
00853155008281IMSIM410182026-03-30
00853155008816IMSIM420712026-03-30
00853155008823IMSIM420722026-03-30
00853155008830IMSIM420732026-03-30
00853155008847IMSIM420742026-03-30
00853155008861IMSIM420762026-03-30
00853620005777MERITMERISET0162026-03-30
00853620005951MERITMHI1000B2026-03-30
06972620114112McGuff0032002026-03-30
06972620114877MERITEX004B2026-03-30
06972620112347Right Way MedicalRWM-IFRF012025-03-21
16972620112351Right Way MedicalRWM-IFRF012025-03-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10813153028312CodanCodan US CorporationFPA2026-07-31
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10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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