AccessGUDID - DEVICE: Aero-Med (10885380175237)

GUDID

Device Identifier (DI) Information

Brand Name: Aero-Med
Version or Model: CA23450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA23450
Company Name: AERO-MED, LLC

Primary DI Number: 10885380175237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194550042 *Terms of Use

Device Description: Bone Marrow Lab Kit, St. Luke's University Health Network, Bethlehem PA Only

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):	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?
60889	Specimen mailer kit	A collection of items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OIB	Blood and urine collection kit (excludes HIV testing)

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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db1e5c6d-8f75-4b4c-aeb4-6e6e402757c8
Public Version Date: May 29, 2025
Public Version Number: 3
DI Record Publish Date: October 07, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50885380175235	10	10885380175237		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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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