Perifix® 332330

GUDID 04046955623716

SD20TDPLOPM SD EPID TRAY

B. BRAUN MEDICAL INC.

Epidural anaesthesia set, medicated

• Primary Device ID: 04046955623716
• NIH Device Record Key: 71fa15f8-c2fd-42b9-94dc-0ccf904a5b5f
• Commercial Distribution Discontinuation: 2023-06-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Perifix®
• Version Model Number: 332330
• Catalog Number: 332330
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955622245 [Primary]
GS1	04046955623716 [Unit of Use]

FDA Product Code

• OGE: Epidural anesthesia kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-30
• Device Publish Date: 2020-06-05

On-Brand Devices [Perifix®]

• 04046964178467: PERIFIX® 18 Ga. x 3&fr ac12; in. (90 mm) Hustead, PERIFIX 20 Ga. Closed Tip Catheter, 5 mL Glas
• 04046964954276: CE17TKFSDTD EPID TRAY W/17GA FIXED WING
• 04046964954252: CE17TKFSDT EPID TRAY W/17GA FIXED WING
• 04046964943294: CE18HKN ACCU-BLOC PERIFIX KIT NRFIT
• 04046964941535: CEP20TON CONT EPID PEDIATRIC SET NRFIT
• 04046964941511: SD20TDN 20 GA SD EPIDURAL TRAY NRFIT
• 04046964941498: SD18TDN 18 GA SD EPIDURAL TRAY NRFIT
• 04046964941474: CE18TKSTN CONT EPID W/SOFT TIP NRFIT
• 04046964941450: CE18TKON PERIFIX ONE EPID FULL TRY NRFIT
• 04046964941436: CE18TKN ACCU-BLOC PERIFIX KIT NRFIT
• 04046964941412: CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT
• 04046964941399: CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT
• 04046964941375: CE17TKFSN EPIDURAL TRAY NRFIT
• 04046964941351: CE17TKFN PERIFIX CONT EPID TRAY NRFIT
• 04046964941337: CE17TKN CONT EPIDURALTUOHY NRFIT
• 04046964940712: EC20CN 20G X 100CM CATH CLOSED NRFIT
• 04046964940699: EC19CFN 19G X 100CM CATH CLOSE TIP NRFIT
• 04046964671067: PERIFIX® 17 Ga. x 4 in . (100 mm) Metal Hub Dull Tuohy, PERIFIX FX 19 Ga. Springwound Open Tip
• 04046964665196: Continuous Epidural Tray
• 04046964561498: GOVCE17TKFCS CONT EPID TR W/17G TUOHY-LF
• 04046964561474: GOVCE17TK CONT EPIDURALTUOHY
• 04046964561450: GOVSD18TK SGL DOSE EPIDURAL TRAY
• 04046964559600: GOVSD20TD SGL DOSE EPIDURAL TRAY
• 04046964558795: GOVCE18HK ACCU-BLOC PERIFIX KIT
• 04046964558771: GOVCE18TKST CONT EPID W/SOFT TIP
• 04046964558733: GOVSD17TD SINGLE DOSE EPID ANESTH
• 04046964558719: GOVSD18TD SGL DOSE EPIDURAL TRAY
• 04046964558672: GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY
• 04046964558658: GOVCE18TK ACCU-BLOC PERIFIX KIT
• 04046964183232: PERIFIX® PinPad™ - securement device for PERIFIX 0.2 µm Flat Epidural Filter
• 04046964180040: 20 Ga. x 40 in. Polyamide/Polyurethan e PERIFIX® ONE Catheter – closed tip with catheter conn
• 04046964180026: 20 Ga. x 40 in. Polyamide PERIFIX® Catheter – closed tip with catheter connector and threadin
• 04046964180002: 20 Ga. x 40 in. Polyamide/Polyurethan e PERIFIX® ONE Pediatric Catheter – closed tip with cat
• 04046964179983: 24 Ga. x 28 in. Polyamide/Polyurethan e PERIFIX® ONE Pediatric Catheter – closed tip with cat
• 04046964179969: 20 Ga. x 40 in. Polyamide Styleted PE RIFIX® Catheter – closed tip with catheter connector an
• 04046964179945: Perifix® SoftTip Epidural Anesthe sia Catheter - 20 Ga. x 40 in., Closed Tip
• 04046964179921: 20 Ga. x 40 in. Polyamide PERIFIX® Catheter – open tip with catheter connector and threading
• 04046964179907: 19 Ga. x 36 in. Radiopaque Polyamide Springwound PERIFIX® FX Catheter – open tip with cathet
• 04046964179884: 19 Ga. x 40 in. Polyamide PERIFIX® Catheter – closed tip with catheter connector and threadin
• 04046964179860: 19 Ga. x 40 in. Polyamide PERIFIX® Catheter – open tip with catheter connector and threading
• 04046964179082: PERIFIX® ONE Continuou s Epidural Set 18 Ga. x 3.5 in. (90mm) Tuohy Needle Set with 20 Ga. Clos
• 04046964179068: PERIFIX® ONE Pediatric Continuous Epidural Set 20 Ga. x 2 in. (50mm) Tuohy Needle Set with 24
• 04046964179044: PERIFIX® 20 Ga. x 2 in . (50 mm) Tuohy, PERIFIX ONE 24 Ga. Closed Tip Catheter, 5 mL Glass Luer
• 04046964179020: PERIFIX® ONE Pediatric Continuous Epidural Set 18 Ga. x 2 in. (50mm) Tuohy Needle Set with 20
• 04046964179006: PERIFIX® 18 Ga. x 2 in . (50 mm) Tuohy, PERIFIX ONE 20 Ga. Closed Tip Catheter, 5 mL Glass Luer
• 04046964178948: PERIFIX® 18 Ga. x 3&fr ac12; in. (90 mm) Tuohy, PERIFIX ONE 20 Ga. Closed Tip Catheter, 5 mL Gl
• 04046964178924: PERIFIX® 18 Ga. x 3&fr ac12; in. (90 mm) Tuohy, PERIFIX 20 Ga. Closed Tip Catheter, 5 mL Glass
• 04046964178900: PERIFIX® 18 Ga. x 3&fr ac12; in. (90 mm) Hustead, PERIFIX 20 Ga. Closed Tip Catheter, 10 mL Gla
• 04046964178887: PERIFIX® 17 Ga. x 3&fr ac12; in. (90 mm) Tuohy, PERIFIX 19 Ga. Closed Tip Catheter, 5 mL Glass
• 04046964178863: PERIFIX® 20 Ga. x 3&fr ac12; in. (90 mm) Tuohy, PERIFIX 8 mL Plastic Luer Slip LOR Tray (Kit)