FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosma Enterprises
DI: 00818634020840
·
Model: 10-9030PTH
·
Bosma Enterprises
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bosma Enterprises
- Primary DI
- 00818634020840
- Version / Model
- 10-9030PTH
- Catalog Number
- 10-9030PTH
- Company Name
- Bosma Enterprises
- Labeler DUNS
- 878070325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-02
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 54ee992f-aa1f-48f5-bb2e-25810b7a1469
Device Description
Patient Transportation PTH Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 40x80 XL Lift Sheet, and STAT-BLOC Disposable Pillowcase.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 37456 | Pillow cover, single-use | A device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. This is a single-use device. | No | Active |
| 37165 | Patient transfer/turning sheet, single-use | A manual device in the form of a sturdy sheet 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818634020847 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00818634020840 | GS1 |
Customer Contacts
- Phone
- 800-362-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat. Keep dry.