AccessGUDID - DEVICE: enFlow™ (10190752125803)

GUDID

Device Identifier (DI) Information

Brand Name: enFlow™
Version or Model: 980121EU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 980121EU
Company Name: AIRLIFE

Primary DI Number: 10190752125803
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119058668 *Terms of Use

Device Description: Controller Model 121

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?
47619	Convection blood/fluid warmer set	A collection of devices used in conjunction with a convection blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It may consist of coiled tubing, or other design, through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, thermal, infusion fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130867	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: Keep Dry
Storage Environment Temperature: between -30 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 57 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb155657-a03c-40e1-b0ef-153be1595f7d
Public Version Date: April 17, 2025
Public Version Number: 4
DI Record Publish Date: March 29, 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

[?]

Phone: +1(833)327-3284
Email: customersupport@vyaire.com

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