NA

Basic Information

• Brand Name: NA
• Primary DI: 00810050243483
• Version / Model: 9019
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: 49840a88-9263-4d60-bb33-181541568afa

Device Description

KIT, SUPPLEMENTAL CHILD ACCESSORY. Includes: 9012-A – HUGGER, PEDIATRIC, FOAM INSERT (00810050242462), 9012-B – HUGGER, PEDIATRIC, BASE (00810050242479), 9012-C – STRAP, PEDIATRIC HUGGER (00810050242486), 9012-D – ADAPTER, PEDIATRIC HUGGER (00810050242493), 9013-A – HUGGER, CHILD, FOAM INSERT (00810050242509), 9013-B – HUGGER, CHILD, BASE (00810050242516), 9013-C – STRAP, CHILD HUGGER (00810050242523), 9013-D – ADAPTER, CHILD HUGGER, TABLE (00810050242530), 9014 – KIT, STRAP (00810050243186), 9015 – KIT, CHILD HEAD REST (00810050243193)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KXJ	Table, Radiologic	Radiology	892.1980	2
PRN	Pediatric Position Holder	General Hospital	880.5680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41058	Multifunction body cushion	A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.	No	Active
45127	Infant whole-body immobilizer, reusable	A device intended to be used to temporarily render an infant's whole body immovable (strait-jacket effect) while the patient undergoes therapeutic or diagnostic interventions. It includes non-rigid fabric and/or plastic components but might also include a rigid structural component (e.g., board). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050243483	GS1