FDA.reportPublic FDA data

RSDL

Primary DI
00817129020006
Brand
RSDL
Company
EMERGENT PROTECTIVE PRODUCTS USA INC.
Model
F5402G
Device description
Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents from the skin.
Published
2019-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MACDecontamination Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MACDecontamination KitGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023969000REACTIVE SKIN DECONTAMINATION LOTIONDept. of the Army2003-03-25MAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817129020003PackageGS160In Commercial Distribution
20817129020000PackageGS14In Commercial Distribution
00817129020006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712902000310817129020003
2081712902000020817129020000
00817129020006008171290200068171290200060817129020006

GMDN Terms#

Term, Definition table
TermDefinition
Hazardous chemical decontamination agent, professionalA substance intended for professional use to decontaminate uninjured skin, garments, and/or non-powered devices that have been contaminated by highly-toxic chemical agents (e.g., VX gas, sarin, soman and iperit), typically on the battlefield or in other emergency settings. It consists of inorganic and/or organic compounds available in various forms (e.g., spray, liquid, gel, foam, powder). After application, this device cannot be reused.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-888-773-3266MedicalInformation@ebsi.com

Regulatory Flags#

DUNS number
079093721
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817129020013RSDLF5408ENG2019-12-02
00817129020082RSDL40021742019-12-02
20817129020000RSDLF5402G2019-12-02
10817129020010RSDLF5408ENG2019-12-02
10817129020089RSDL40021742019-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618029791399SageSAGE PRODUCTS, LLCMAC2023-10-22
00618029830241SageSAGE PRODUCTS, LLCMAC2023-10-22
00618029850188SageSAGE PRODUCTS, LLCMAC2023-10-22
50618029850183SageSAGE PRODUCTS, LLCMAC2023-10-22
05391540450079ABD DeviceAQUILA BIOSCIENCE LIMITEDMAC2022-12-01
20653160139161CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
00653160233421CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160233428CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160139164CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160240754CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160287919CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160294207CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160313120CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160019285CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160019964CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160021868CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160024975CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160027075CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160053203CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160065848CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160119411CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160201024CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160209891CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160019280CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160019969CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160021863CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160024970CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160027070CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160053208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160065843CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01