FDA.reportPublic FDA data

RSDL

Primary DI
10817129020089
Brand
RSDL
Company
EMERGENT PROTECTIVE PRODUCTS USA INC.
Model
4002174
Published
2019-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10817129020089PackageGS140In Commercial Distribution
00817129020082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712902008910817129020089
00817129020082008171290200828171290200820817129020082

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079093721
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
00817129020006RSDLF5402G2019-12-02
00817129020013RSDLF5408ENG2019-12-02
00817129020082RSDL40021742019-12-02
20817129020000RSDLF5402G2019-12-02
10817129020010RSDLF5408ENG2019-12-02

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