Safti Cuff 900911

GUDID 30815112021666

Safticuff SL Airway

Bracco Diagnostics Inc.

Barium enema catheter
Primary Device ID30815112021666
NIH Device Record Key09b55f87-35e2-40b6-a7a8-4fdd7f62c754
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafti Cuff
Version Model Number900911
Catalog Number900911
Company DUNS849234661
Company NameBracco Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx

Device Dimensions

Catheter Gauge48 French
Catheter Gauge48 French
Catheter Gauge48 French
Catheter Gauge48 French
Catheter Gauge48 French
Catheter Gauge48 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112021662 [Primary]
GS130815112021666 [Package]
Contains: 10815112021662
Package: [75 Units]
In Commercial Distribution

FDA Product Code

FGDCatheter, Retention, Barium Enema With Bag

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30

Devices Manufactured by Bracco Diagnostics Inc.

00815112021535 - Junior Flexi Tip Pediatric Enema Tip2025-06-09 Junior Flexi Tip
10815112021556 - SaftiCuff DK2025-06-09 Safticuff DL Airway
10815112021563 - Super XL Enema System2025-06-09 SXL w/Att. (Silicone Cuff)
30815112021581 - Enema Kit: Empty Enema Bag Delivery System2025-06-09 Empty Snap Cap Bag
10815112021594 - EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System2025-06-09 Empty Exacta l Bag
10815112021624 - 24 Fr Infant Flexi Tip: Pediatric Enema Tip2025-06-09 Infant Flexi Tip
30815112021635 - Miller Enema Air Tip: Without Retention Cuff2025-06-09 Miller Air Tip
00815112021641 - 14 French Pediatric Flexi Tip2025-06-09 14 Fr Pediatric Flexi Tip

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