AccessGUDID - DEVICE: N/A (10885403057120)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 4545A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4545A
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403057120
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: Amniocentesis Tray, 20 G x 3 1/2 Inch Spinal Needle With Centimeter Depth Markings

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
35496	Amniocentesis kit, medicated, single-use	A collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIO	SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e64b156d-11c6-4731-8e44-6c771d5006de
Public Version Date: December 20, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2016