AccessGUDID - DEVICE: BD Difco™ Haemophilus Influenzae Antiserum Type a (00382902225010)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ Haemophilus Influenzae Antiserum Type a
Version or Model: 222501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 222501
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902225010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Difco™ Haemophilus Influenzae Antiserum Type a, 1 mL

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
50975	Haemophilus influenzae culture isolate antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from one or multiple strains of Haemophilus influenzae bacteria isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GRP	ANTISERA, ALL TYPES, H. INFLUENZA

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: 2d5f6cb2-4330-438c-8bea-b2c46e69d7b6
Public Version Date: July 24, 2024
Public Version Number: 4
DI Record Publish Date: April 28, 2016