FDA UDI
In Commercial Distribution
🇺🇸 United States
Barrier® EasyWarm®
DI: 07333350371685
·
Model: 629905
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Barrier® EasyWarm®
- Primary DI
- 07333350371685
- Version / Model
- 629905
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-01
- Public Version
- 1
- Public Version Date
- 2024-11-11
- Public Version Status
- New
- Public Device Record Key
- 607cf11a-5d2f-4e97-817b-4032a2f5b521
Device Description
EasyWarm, ACTIVE SELF-WARMING BLANKET, 92x152 cm
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
- 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 |
|---|---|---|---|---|
| 58416 | Activated-medium surgical warming blanket | A non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover. It is a highly hygienic device made of plastic material and designed with integrated pockets that hold air-activated warming pads containing various media [e.g., active coal, clay, or salt and iron (Fe) powder] that chemically generate heat when the device is removed from its sealed packaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333350154653 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 07333350371685 | GS1 |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232508 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | One Size |