DEVICE: Bosma Enterprises (00818634020413)
Device Identifier (DI) Information
Bosma Enterprises
10-8020CR
In Commercial Distribution
10-8020CR
Bosma Enterprises
10-8020CR
In Commercial Distribution
10-8020CR
Bosma Enterprises
Accelerate-OR CR Kit; Each Kit Includes QuickSuite Kit, 20x29 Disposable Pillowcase, Disposable Washcloth (2) and Disposable Rayon Mop Head.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
65175 | Operating room turnover kit |
A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.
|
Active | false |
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.
|
Active | false |
47454 | Basic pillowcase, single-use |
A protective envelope for a pillow typically made of a thin-textile or reinforced-paper material intended to create a physical barrier to soiling and cross-contamination. 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).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PWU | Clean-Up Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Avoid excessive heat. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7a515155-fa63-43f5-85b0-3b678e018d9e
July 04, 2022
2
July 02, 2021
July 04, 2022
2
July 02, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10818634020410 | 8 | 00818634020413 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-362-5463
kimm@bosma.org
kimm@bosma.org