FDA.report

NeoGrip Orange

Primary DI
00812594012136
Brand
NeoGrip Orange
Company
NEOTECH PRODUCTS, INC.
Model
10812594012133
Catalog number
N602O
Device description
Tubing and Cable Holder (Qty. 40)
Published
2021-05-19
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
true

Related Records

Product Codes

CodeName
JAYSupport, Breathing Tube

Product Code Classifications

CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10812594012133PrimaryGS10
00812594012136Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401213310812594012133
00812594012136008125940121368125940121360812594012136

GMDN Terms

TermDefinition
Cable/lead holderA device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
198013435
Device count
40
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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