FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Animas 2.0 mL Cartridge
DI: 10840406100136
·
Model: 10012402
·
ANIMAS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Animas 2.0 mL Cartridge
- Primary DI
- 10840406100136
- Version / Model
- 10012402
- Catalog Number
- 10012402
- Company Name
- ANIMAS CORPORATION
- Labeler DUNS
- 968998641
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 4
- Public Version Date
- 2021-08-04
- Public Version Status
- Update
- Public Device Record Key
- 3b92e296-1dd2-4a0e-bf3f-ebc977951bb7
- Distribution End Date
- 2020-07-21
Device Description
CARTRIDGE, STAMPED (ETO STERILE SGL)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OYC | Pump, infusion, insulin, to be used with invasive glucose sensor | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64891 | Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm | A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840406100129 | GS1 | 10 | Not in Commercial Distribution | 2020-07-21 | |
| Primary | 10840406100136 | GS1 | ||||
| Package | 10840406100174 | GS1 | 2 | Not in Commercial Distribution | 2020-07-21 |
Customer Contacts
- Phone
- +1(877)937-7867
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry