DEVICE: Bosma Enterprises (00818634020352)
Device Identifier (DI) Information
Bosma Enterprises
10-8020BIO
In Commercial Distribution
10-8020BIO
Bosma Enterprises
10-8020BIO
In Commercial Distribution
10-8020BIO
Bosma Enterprises
Accelerate-OR BIO Kit; Each Kit Includes Sahara OR Table and Draw/Lift Sheet, Patient Strap, STAT-BLOC Disposable Antimicrobial Impervious Armboard Cover with Straps (2), 40x40 Clear 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 24x32 Clear Liner 1.0 mil 15 gal Bag (4), 38x47 Buff Color 1.8 mil Waste Bag (3), 18x24 Clear 2 mil 100% Cotton Double Drawstring Bag, Suction Tubing (2), Suction Liner 3000cc (2) and 16 oz Banded 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.
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Active | false |
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.
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Active | false |
44851 | Limb/torso/head restraint, single-use |
A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.
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Active | false |
16779 | Suction/irrigation tubing, single-use |
A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.
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Active | false |
44942 | Suction system canister liner |
A device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.
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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 |
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Special Storage Condition, Specify: Avoid excessive heat. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
aa508ffc-a948-45b9-9526-8032cad12906
October 21, 2024
3
July 02, 2021
October 21, 2024
3
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 |
---|---|---|---|---|---|
10818634020359 | 8 | 00818634020352 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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