FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosma Enterprises
DI: 00818634020437
·
Model: 10-8020DA
·
Bosma Enterprises
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bosma Enterprises
- Primary DI
- 00818634020437
- Version / Model
- 10-8020DA
- Catalog Number
- 10-8020DA
- 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
- 1
- Public Version Date
- 2021-07-12
- Public Version Status
- New
- Public Device Record Key
- f11d5f3c-db47-49d1-a54d-084688e2d2c1
Device Description
Accelerate-OR DA Kit; Each Kit Includes QuickSuite Kit, and STAT-BLOC Disposable Antimicrobial Impervious Pillowcase (2).
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 |
| 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 | 10818634020434 | GS1 | Case | 16 | In Commercial Distribution | |
| Primary | 00818634020437 | GS1 |
Customer Contacts
- Phone
- 800-362-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat. Keep dry.