FDA.reportPublic FDA data

Anexa Biomedical

Primary DI
00850067990895
Brand
Anexa Biomedical
Company
ANEXA BIOMEDICAL, INC.
Model
91000
Device description
91000 - 1000mL Bottle USP Sterile Saline 0.9% Sodium Chloride
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K161658000
K172486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161658000Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc.2016-09-14FRO
K172486000Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottleAnexa Biomedical, Inc.2017-09-21FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850067990819PackageGS16In Commercial Distribution
00850067990895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850067990819008500679908198500679908190850067990819
00850067990895008500679908958500679908950850067990895

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, salineA 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.

Contacts#

Phone, Email table
PhoneEmail
817-914-0188po@anexabio.com

Regulatory Flags#

DUNS number
965567006
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
true
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
00850067990086Anexa Biomedical81002026-07-06
00850067990178Anexa Biomedical81202026-07-06
00850067990260Anexa Biomedical82502026-07-06
00850067990352Anexa Biomedical85002026-07-06
00850067990444Anexa Biomedical91002026-07-06
00850067990536Anexa Biomedical91202026-07-06
00850067990628Anexa Biomedical92502026-07-06
00850067990710Anexa Biomedical95002026-07-06
00850067990802Anexa Biomedical810002026-07-06

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Primary DI, Brand, Company table
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29