AccessGUDID - DEVICE: EMSRUN (06974567741260)

GUDID

Device Identifier (DI) Information

Brand Name: EMSRUN
Version or Model: PZDM0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wuxi Emsrun Technology Co., Ltd.

Primary DI Number: 06974567741260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 542972552 *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:	Yes
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?
40744	Radiation prep-pad warmer	A mains electricity (AC-powered) device designed to heat factory-sealed prep pads (skin cleansing pads typically containing alcohol or povidone iodine), with a pre-set maximum temperature (e.g., 55?C) for the purpose of warming the pads prior to use on a paediatric patient, notably to reduce the number of venous access attempts (needle sticks). The device is typically of tabletop design and includes a heat exchanger that uses electromagnetic radiation (e.g., radio-frequency, microwaves) to transmit heat to the packaged pads that have been placed in separate compartments within the device; it also includes temperature controls and/or alarms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High Intensity Light or Pulse Light

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: a8bce6e9-2afd-4f7d-a290-ddf0dbcde91a
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022

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

Customer Contact

[?]

No Customer Contact currently defined

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