N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10885403057120
• Version / Model: 4545A
• Catalog Number: 4545A
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-12-20
• Public Version Status: Update
• Public Device Record Key: e64b156d-11c6-4731-8e44-6c771d5006de
• Distribution End Date: 2023-12-20

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIO	SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)	Obstetrics/Gynecology	884.1550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403057128	GS1	Case	10	Not in Commercial Distribution	2023-12-20
Primary	10885403057120	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius