FDA UDI
In Commercial Distribution
🇺🇸 United States
ICU Medical
DI: 00840619082482
·
Model: CH2005
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ICU Medical
- Primary DI
- 00840619082482
- Version / Model
- CH2005
- Catalog Number
- CH2005
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-27
- Public Version
- 1
- Public Version Date
- 2021-08-04
- Public Version Status
- New
- Public Device Record Key
- 31f349a0-dce0-4e96-8ff3-3b5c11b78188
Device Description
5mL Syringe w/Spinning Spiros™, Red Cap
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONB | Closed antineoplastic and hazardous drug reconstitution and transfer system | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43324 | Fluid transfer set, general-purpose | A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840619082489 | GS1 | CS | 50 | In Commercial Distribution | |
| Primary | 00840619082482 | GS1 |
Customer Contacts
- Phone
- +1(866)829-9025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173477 | 000 |