Redi-ACE - Mini 472004000

GUDID 05707480161522

Curaplex collar Mini - Ambu Redi-ACE

Ambu A/S

Cervical spine collar, single-use
Primary Device ID05707480161522
NIH Device Record Keyc89802a2-95ea-40ed-a63d-14b1c91794bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameRedi-ACE - Mini
Version Model Number472004000
Catalog Number472004000
Company DUNS305682023
Company NameAmbu A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480120062 [Primary]
GS105707480161522 [Package]
Contains: 05707480120062
Package: [30 Units]
In Commercial Distribution

FDA Product Code

IQKOrthosis, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-30
Device Publish Date2022-12-09

Devices Manufactured by Ambu A/S

05707480006397 - Perfit Collar™2026-01-30 Collar Perfit Infant size 1
05707480006403 - Perfit Collar™2026-01-30 Collar Perfit Pediatric size 2
05707480006410 - Perfit Collar™2026-01-30 Collar Perfit Neckless, size 3
05707480006427 - Perfit Collar™2026-01-30 Collar Perfit short size 4
05707480006434 - Perfit Collar™2026-01-30 Collar Perfit regular, size 5
05707480006441 - Perfit Collar™2026-01-30 Collar Perfit tall size 6
05707480006458 - Perfit Collar™2026-01-30 Collar Perfit Regular size 1
05707480006465 - Perfit Collar™2026-01-30 Collar Perfit Pediatric, size 2, cases of 50 PCS

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