FDA UDI
In Commercial Distribution
🇺🇸 United States
warmUP
DI: 00851137008014
·
Model: WU-200L
·
Avacore Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- warmUP
- Primary DI
- 00851137008014
- Version / Model
- WU-200L
- Catalog Number
- WU-200L
- Company Name
- Avacore Technologies, Inc.
- Labeler DUNS
- 036950975
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-07
- Public Version
- 1
- Public Version Date
- 2025-01-15
- Public Version Status
- New
- Public Device Record Key
- 4795544a-f279-4274-b591-c28c0df1f419
Device Description
Arm Warming Sleeve Large
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36956 | External circulating-fluid core temperature regulation system control unit, heating/cooling | An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851137008014 | GS1 | ||||
| Package | 10851137008011 | GS1 | inner pack | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-888-282-2673
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040911 | 000 |