FDA.reportPublic FDA data

NeoDevices, Inc.

Primary DI
10816340027808
Brand
NeoDevices, Inc.
Company
NEODEVICES INC
Model
ND-BF20
Device description
Blood filter 17 micron
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10816340027808PackageGS125In Commercial Distribution
10816340022117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081634002780810816340027808
1081634002211710816340022117

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion filterA microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-636-6285info@neodevices.com

Regulatory Flags#

DUNS number
189670230
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816340021632EL-SPIKE-MEL-SPIKE-M2026-06-01
00816340021649EL-SPIKE-FEL-SPIKE-F2026-06-01
00816340021656EL-S55-HFEL-S55-HF2026-06-01
00816340023162Transfer StrawND-S552026-02-05
10816340023145Marian MedicalETT-A-15502025-03-28
10816340021523NeoDevices, Inc.ND60-EL2016-09-24
10816340028355NeoDevices, Inc.ND60-EL2016-09-24
00816340023131SS-1660.13SS-1660.132024-04-17
10816340021097NeoDevices, Inc.LN22102016-09-24
10816340021103NeoDevices, Inc.LN22152016-09-24
10816340027921NeoDevices, Inc.LN22102016-09-24
10816340027938NeoDevices, Inc.LN22152016-09-24
10816340022117NeoDevices, Inc.ND-BF202016-09-24
00816340023124CT KITCT KIT2023-02-09
10816340023121CT KITCT KIT2023-02-09
10816340023008NeoDevices, Inc.ND-S3EL2016-09-24
10816340023015NeoDevices, Inc.ND-S5EL2016-09-24
10816340023022NeoDevices, Inc.ND-S10EL2016-09-24
10816340023039NeoDevices, Inc.ND-S20EL2016-09-24
10816340023046NeoDevices, Inc.ND-S30EL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23