AccessGUDID - DEVICE: Munchkin (00735282281310)

GUDID

Device Identifier (DI) Information

Brand Name: Munchkin
Version or Model: MKFE0951 Rev 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28131
Company Name: MUNCHKIN, INC.

Primary DI Number: 00735282281310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787026855 *Terms of Use

Device Description: Munchkin Flow Nipple Shield Replacement Kit - 16mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Kit:	Yes
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?
35337	Nipple shielding teat, reusable	A device in the form of a flexible dome with milk-flow holes designed to be worn on a nipple by a nursing mother to facilitate breast feeding when an infant has latch-on problems (i.e., aberrant suckling technique), is premature, ill, or small (suction inside the device holds the nipple in an extended position), or when the mother has flat or inverted nipples (it provides sensation deep in the mouth that stimulates the baby). It is typically made of preformed silicone materials that additionally provide nipple protection. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFS	Shield, Nipple

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: Yes

Sterilization Method [?]
Liquid Chemical

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: 5d2512a2-b08d-46fa-b179-5be0a011f2be
Public Version Date: November 22, 2024
Public Version Number: 1
DI Record Publish Date: November 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10735282281317	6	00735282281310		In Commercial Distribution	Case

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 818 293-5000
Email: Vartan.Chldrian@munchkin.com

Phone: 818 293-5000
Email: nelson.ipapo@munchkin.com

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