FDA.report

HOSE SET, ADVANCE CONTROL PADS

Primary DI
10842430104487
Brand
HOSE SET, ADVANCE CONTROL PADS
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5996-35
Catalog number
5996-12
Published
2019-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCXSupport, Patient Position

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10842430104487PackageGS112In Commercial Distribution
00842430104480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084243010448710842430104487
00842430104480008424301044808424301044800842430104480

GMDN Terms

TermDefinition
External cuff/pad inflation tubing setA collection of devices consisting of flexible tubes, connectors, and supportive devices (e.g., clamp) intended to be used to deliver air from a pump to a noninvasive, patient-contact pad, pack, cuff or cushion. It may be intended for use with a specific type of assembly (e.g., alternating-pressure pump tubing set). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags

DUNS number
084527241
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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