RSDL
GUDID 20817129020000
EMERGENT PROTECTIVE PRODUCTS USA INC.
Hazardous chemical decontamination agent, professional| Primary Device ID | 20817129020000 |
| NIH Device Record Key | fbed5dd1-a444-4887-96cf-c9029d525d97 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RSDL |
| Version Model Number | F5402G |
| Company DUNS | 079093721 |
| Company Name | EMERGENT PROTECTIVE PRODUCTS USA INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com | |
| Phone | 1-888-773-3266 |
| MedicalInformation@ebsi.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817129020006 [Primary] |
| GS1 | 10817129020003 [Package] Contains: 00817129020006 Package: Case [60 Units] In Commercial Distribution |
| GS1 | 20817129020000 [Package] Contains: 10817129020003 Package: Overpack [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023969
FDA Product Code
| MAC | Decontamination Kit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-10 |
| Device Publish Date | 2019-12-02 |
On-Brand Devices [RSDL]
| 10817129020089 | 4002174 |
| 10817129020010 | F5408ENG |
| 20817129020000 | F5402G |
Trademark Results [RSDL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RSDL 98673767 not registered Live/Pending |
Emergent BioSolutions Canada Inc. 2024-07-30 |
 RSDL 86432665 not registered Dead/Abandoned |
EMERGENT PROTECTIVE PRODUCTS CANADA ULC 2014-10-23 |
 RSDL 86269566 4753144 Live/Registered |
EMERGENT PROTECTIVE PRODUCTS CANADA ULC 2014-05-02 |
 RSDL 78629079 3432719 Live/Registered |
EMERGENT PROTECTIVE PRODUCTS CANADA ULC 2005-05-12 |
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