FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosma Enterprises
DI: 00818634025586
·
Model: 10-9030PTW
·
Bosma Enterprises
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bosma Enterprises
- Primary DI
- 00818634025586
- Version / Model
- 10-9030PTW
- Catalog Number
- 10-9030PTW
- Company Name
- Bosma Enterprises
- Labeler DUNS
- 878070325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-15
- Public Version
- 1
- Public Version Date
- 2024-03-25
- Public Version Status
- New
- Public Device Record Key
- db7dfcc3-8bd3-4731-bb16-ff2e49a70663
Device Description
Patient Transportation PTW Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Partially-Fitted Gurney Sheet, STAT-BLOC Disposable Pillowcase, 40x80 Disposable XL Lift Sheet, and Z-Slider Patient Transfer Sheet
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 |
|---|---|---|---|---|
| 37163 | Patient transfer sliding mat | A manual device typically in the form of an open roll mat or flat sheet designed to be used by healthcare professionals to assist in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the patient. It is typically designed using low-friction artificial fibres and intended to be slid under the patient who is then gently pushed by attending staff to glide across the surface of the device. | No | Obsolete |
| 62619 | Surgical linen/cushion set | A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818634025583 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00818634025586 | GS1 |
Customer Contacts
- Phone
- 800-362-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat; keep dry.