AccessGUDID - DEVICE: AIM (15099169457383)

GUDID

Device Identifier (DI) Information

Brand Name: AIM
Version or Model: 4500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VITALOGRAPH (IRELAND) LIMITED

Primary DI Number: 15099169457383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219683489 *Terms of Use

Device Description: 45738

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?
42629	Aerosol inhalation monitor	An electronic device intended to be used in the assessment and training of a patient's inhalation flow rates and "firing" coordination when using an aerosol metered dose inhaler (MDI) or a dry powder inhaler (DPI). It is typically known as an aerosol inhalation monitor (AIM), and includes a display/control panel, an electronic flowmeter, a placebo MDI aerosol canister, and a flowhead with mouthpiece. The patient demonstrates his/her inhalation technique while the healthcare provider observes their performance; a visual incentive training device to encourage and motivate the patient, especially children, may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWF	SPIROMETER, THERAPEUTIC (INCENTIVE)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K893665	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
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e60ca46b-28c5-4ce4-aec9-6d0ed368137a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 21, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
35099169457387	25	05099169457386		In Commercial Distribution
05099169457386	1	15099169457383		In Commercial Distribution

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

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES