AccessGUDID - DEVICE: Apgar-Timer (07612367017428)

GUDID

Device Identifier (DI) Information

Brand Name: Apgar-Timer
Version or Model: 017.0015
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medela AG

Primary DI Number: 07612367017428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488293218 *Terms of Use

Device Description: Apgar-Timer for standard rail (10x25mm)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 746a8df6-1a15-4f67-b9cf-79e83c4a688d
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023

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

[?]

Phone: +1-877-735-1626
Email: info-healthcare@medela.com

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