FDA.report

Prep Kit - Midmark IQholter, 7-lead

Primary DI
00841709100703
Brand
Prep Kit - Midmark IQholter, 7-lead
Company
MIDMARK CORPORATION
Model
2-100-0090
Catalog number
2-100-0090
Device description
These kits are designed to provide the supplies you need for Holter testing. Kit includes: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and seven electrodes.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications

CodeDeviceSpecialtyClass
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841709100700PackageGS130In Commercial Distribution
00841709100703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084170910070010841709100700
00841709100703008417091007038417091007030841709100703

GMDN Terms

TermDefinition
Electrocardiographic long-term ambulatory recording support kitA collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1-(800)624-8950techsupport@midmark.com

Regulatory Flags

DUNS number
005036025
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
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