FDA.reportPublic FDA data

NeilMed Wound Wash

Primary DI
00705928652101
Brand
NeilMed Wound Wash
Company
NEILMED PHARMACEUTICALS, INC.
Model
WoundWash
Catalog number
WW-0NB-48-ENU-USL
Device description
NeilMed Wound Wash - Sterile Saline Solution Ready to UseIsotonic-Drug Free-Preservative Free
Published
2020-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123910000WOUNDWASH SALINE SPRAYNeilmed Pharmaceuticals, Inc.2013-10-29FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00705928652101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00705928652101007059286521017059286521010705928652101

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, saline, sterileA sterile solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight177.6Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (707) 525-3784quality@neilmed.com

Regulatory Flags#

DUNS number
799295915
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00705928603691NeilMed EustachiME82032026-04-27
00705928002043NeilMed Sinus RinsePediatric, 120 Premixed Sachets2023-03-02
00705928003002NeilMed Sinus RinsePediatric, 60 Premixed Sachets2023-03-02
00705928003101Sinus Rinse KitIsotonic, 10ct Packets/Sachets2023-03-02
00705928004009NeilMed Sinus Rinse Refill BoxHypertonic, 70 Premixed Packets2023-03-02
00705928014008NeilMed Sinus Rinse KitPediatric, 30ct Packets/Sachets2023-03-02
00705928052000NeilMed Sinus Rinse Refill BoxIsotonic, 50ct Packets/Sachets2023-03-02
00705928001008NeilMed Sinus RinseNeilMed Sinus Rinse Kit 60 Premixed Sachets2022-10-17
00705928000995NeilMed NasogelNasogel TubeNG-6R-96-ENU-USL2022-07-04
00705928045309NeilMed NasogelNasogel SprayGSP30-6R-96-ENU-USL2022-07-04

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Primary DI, Brand, Company table
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04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
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00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29