FDA UDI
In Commercial Distribution
🇺🇸 United States
ICU Medical
DI: 00840619081324
·
Model: CH3927
·
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
- 00840619081324
- Version / Model
- CH3927
- Catalog Number
- CH3927
- 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
- 51a5592a-ab06-4f21-86b3-5e5dd38c71bb
Device Description
Oncology Kit w/20" Ext Set w/MicroClave™, Graduated Connector, Clamp, Transfer Set w/Spiros™, 13mm Closed Vial Spike w/Clave™
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12170 | Intravenous administration tubing extension set | A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840619081321 | GS1 | CS | 50 | In Commercial Distribution | |
| Primary | 00840619081324 | GS1 |
Customer Contacts
- Phone
- +1(866)829-9025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081361 | 000 |