AccessGUDID - DEVICE: DR200 (M581NEMK950)

GUDID

Device Identifier (DI) Information

Brand Name: DR200
Version or Model: DR200 5L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NEMK95
Company Name: Northeast Monitoring, Inc.

Primary DI Number: M581NEMK950
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837441815 *Terms of Use

Device Description: DR200 holter recorder w/ 5L patient cable

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36827	Electrocardiographic long-term ambulatory recording analyser	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWJ	Electrocardiograph, Ambulatory (Without Analysis)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061293	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: allowed storage conditions: -40C to 70C

Clinically Relevant Size

[?]

Size Type Text
Length: 8.6 Centimeter
Width: 6.0 Centimeter
Depth: 2.0 Centimeter
Weight: 70.9 Gram

Device Record Status

Public Device Record Key: f33148c8-0227-4239-bbb2-e5adcb6b5a6c
Public Version Date: November 04, 2021
Public Version Number: 1
DI Record Publish Date: October 27, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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