FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile Burn Blanket
DI: 00857048006200
·
Model: 1
·
H&H MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sterile Burn Blanket
- Primary DI
- 00857048006200
- Version / Model
- 1
- Catalog Number
- HHSBB01
- Company Name
- H&H MEDICAL CORPORATION
- Labeler DUNS
- 072656713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 1
- Public Version Date
- 2021-01-08
- Public Version Status
- New
- Public Device Record Key
- 441797ed-8910-46a0-b558-cbff635079d0
Device Description
H&H Sterile Burn Blanket, a mylar non-adherent sheet sterilized for use in wrapping large burn areas and protecting them from heat and moisture loss.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FPY | Sheet, Burn | General Hospital | 880.5180 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59215 | Non-adherent bed sheet | A large piece of sterile material intended to cover the mattress of a bed occupied by a patient receiving open-wound treatment, primarily in cases of wounds that have breached the dermis (e.g., extensive burns, cauterizations, and abrasions). It is typically composed of a skin-contact surface (e.g., aluminized, non-woven fabric) designed to prevent adherence to wounds, and thus decrease the potential for trauma, with multiple additional layers designed to diffuse/absorb wound exudate. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857048006200 | GS1 |
Customer Contacts
- Phone
- 804-642-3663
- [email protected]