FDA.report

Midmark IQholter® Digital Holter Recorder Kit

Primary DI
00841709100628
Brand
Midmark IQholter® Digital Holter Recorder Kit
Company
MIDMARK CORPORATION
Model
4-000-0119
Catalog number
4-000-0119
Device description
Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt.
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
false

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
00841709100628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709100628008417091006288417091006280841709100628

GMDN Terms

TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius70 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
false
Serial number
true
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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00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
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