Perfit Collar™ 000264204

GUDID 05707480006427

Collar Perfit short size 4

Ambu A/S

Cervical spine collar, single-use
Primary Device ID05707480006427
NIH Device Record Key9f57542e-cfa0-40da-bf8a-e2abbb07da8c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerfit Collar™
Version Model Number000264204
Catalog Number000264204
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 Datetrue
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
GS105707480006427 [Package]
Contains: 05707480024544
Package: [20 Units]
In Commercial Distribution
GS105707480024544 [Primary]

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 Date2022-12-08

On-Brand Devices [Perfit Collar™]

05707480006502COLLAR PERFIT TALL SIZE6
05707480006496Collar Perfit Regular size 5
05707480006489Collar Perfit Short size 4
05707480006472Collar Perfit Neckless, size 3, cases of 50 Pcs.
05707480006465Collar Perfit Pediatric, size 2, cases of 50 PCS
05707480006458Collar Perfit Regular size 1
05707480006441Collar Perfit tall size 6
05707480006434Collar Perfit regular, size 5
05707480006427Collar Perfit short size 4
05707480006410Collar Perfit Neckless, size 3
05707480006403Collar Perfit Pediatric size 2
05707480006397Collar Perfit Infant size 1

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