FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosma Enterprises
DI: 00818634025890
·
Model: 10-8020TOH
·
Bosma Enterprises
Product Codes
1
GMDN Terms
3
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bosma Enterprises
- Primary DI
- 00818634025890
- Version / Model
- 10-8020TOH
- Catalog Number
- 10-8020TOH
- Company Name
- Bosma Enterprises
- Labeler DUNS
- 878070325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 54e871da-f1a4-42d2-b402-fdb501fab9af
Device Description
Accelerate-OR TOH Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x80 Disposable XL Lift Sheet, Disposable Short Sleeve Blue Isolation Gown 3X and 13x17 Disposable Pillow.
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PWU | Clean-Up Kit | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37165 | Patient transfer/turning sheet, single-use | A manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device. | No | Active |
| 47447 | Bed blanket, single-use | A large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated). | No | Active |
| 47452 | Bed pillow, single-use | A sealed cloth case stuffed with soft material (e.g., foam rubber) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818634025897 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00818634025890 | GS1 |
Customer Contacts
- Phone
- (800) 362-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat; keep dry.