FDA UDI
Not in Commercial Distribution
🇺🇸 United States
COE SPRAY™ II
DI: D6585571281
·
Model: 557128
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- COE SPRAY™ II
- Primary DI
- D6585571281
- Version / Model
- 557128
- Catalog Number
- 557128
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 3
- Public Version Date
- 2018-05-02
- Public Version Status
- Update
- Public Device Record Key
- 8ece1b79-34a7-4f69-b3d3-8ab1600173de
- Distribution End Date
- 2018-05-01
Device Description
COE SPRAY™ II Gallon Refill (3.8L)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRJ | Disinfectant, medical devices | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38773 | Medical device-decontamination agent | A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D6585571282 | HIBCC | 4 | Not in Commercial Distribution | 2017-05-18 | |
| Primary | D6585571281 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep containers tightly sealed when not in use. Store container indoors and in a dry area. Keep from freezing. Use from original container only.