AccessGUDID - DEVICE: CPR Timer (04942962603669)

GUDID

Device Identifier (DI) Information

Brand Name: CPR Timer
Version or Model: 60366
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60366
Company Name: ATOM MEDICAL CORPORATION

Primary DI Number: 04942962603669
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690632047 *Terms of Use

Device Description: No description.

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):	No
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?
35533	Apgar score timer	A device used during childbirth to measure and indicate a length of time at predetermined intervals from the setting time; this being when the baby is born. The time intervals are typically 1, 5 and 10 minutes. It is used to determine the physical health of a newborn infant and its response to birth and life outside the womb according to a weighed score named after the name of the inventor, Virginia Apgar, who devised the Apgar score, which commonly transpires as: Appearance (colour), Pulse (heartbeat), Grimace (reflex), Activity (muscle tone), and Respiration/breathing (APGAR). The total numerical score is 10.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHB	Timer, Apgar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 18 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48882f4e-8c40-4a80-a589-48b08145ec21
Public Version Date: January 29, 2019
Public Version Number: 3
DI Record Publish Date: September 21, 2016

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +81 488533661
Email: hitoshi.hayashi@atomed.co.jp

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