FDA.reportPublic FDA data

neria™ guard

Primary DI
05705244022232
Brand
neria™ guard
Company
Unomedical A/S
Model
704060-5229
Device description
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Published
2020-01-24
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05705244022249PackageGS180Not in Commercial Distribution
05705244022232PrimaryGS10
05705244022256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05705244022249057052440222495705244022249
05705244022232057052440222325705244022232
05705244022256057052440222565705244022256

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle90degree
Depth9Millimeter
Length60Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the product at room temperature. Keep the product away from direct sunlight and any humid environment.

Contacts#

Phone, Email table
PhoneEmail
9999999999xx@xx.xx

Regulatory Flags#

DUNS number
306032491
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05705244027176iLet FlexFG000063-092025-12-14
05705244026872iLet FlexFG000063-022025-12-14
05705244026902iLet FlexFG000063-042025-12-14
05705244026933iLet FlexFG000063-062025-12-14
05705244026964iLet FlexFG000063-082025-12-14
05705244026995iLet FlexFG000063-102025-12-14
05705244027022iLet FlexFG000063-122025-12-14
05705244027053iLet FlexFG000063-012025-12-14
05705244027084iLet FlexFG000063-032025-12-14
05705244027114iLet FlexFG000063-052025-12-14
05705244027145iLet FlexFG000063-072025-12-14
05705244027206iLet FlexFG000063-112025-12-14
05705244026865iLet FlexFG000063-022025-12-14
05705244026889iLet FlexFG000063-042025-12-14
05705244026926iLet FlexFG000063-062025-12-14
05705244026957iLet FlexFG000063-082025-12-14
05705244026988iLet FlexFG000063-102025-12-14
05705244027015iLet FlexFG000063-122025-12-14
05705244027046iLet FlexFG000063-012025-12-14
05705244027060iLet FlexFG000063-032025-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
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
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23