FDA.reportPublic FDA data

SAFE SEDATE®

Primary DI
00612649205014
Brand
SAFE SEDATE®
Company
King Systems Corporation
Model
KS2-SSLARGEUNSC
Catalog number
KS2-SSLARGEUNSC
Device description
Note: KS2-SSLARGEUNSC is new part number for KS2SSLARGEUNSCE. Product did not change.
Published
2020-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMASK, GAS, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649176093PackageGS112Not in Commercial Distribution
00612649205014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649176093006126491760936126491760930612649176093
00612649205014006126492050146126492050140612649205014

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
009299017
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612649196398ADULT ANESTHESIABREATHING CIRCUIT8403F-80Z8403F-80Z2016-09-22
00612649198552ADULT ANESTHESIA8600B-848600B-842020-10-21
00612649198651ADULT ANESTHESIABREATHING CIRCUIT8603F-6121Z8603F-6121Z2016-09-22
00612649198668ADULT ANESTHESIABREATHING CIRCUIT8603F-61Z8603F-61Z2016-09-22
00612649200033UNIVERSAL F2®C0120-230C0120-2302022-12-13
00612649200071UNIVERSAL F2®C060-230C060-2302023-01-16
00612649200118UNIVERSAL F2®C090-230C090-2302022-12-13
00612649200125UNIVERSAL F2®C090-61C090-612022-12-13
00612649200149UNIVERSAL F2®C360-61ZC360-61Z2022-12-13
00612649200323ADULT ANESTHESIABREATHING CIRCUITCP-01084CP-010842016-09-22
00612649200934UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD360-808ZD360-808Z2016-09-22
00612649201078UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD366-618ZD366-618Z2016-09-22
00612649201214UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-16421ZD395-16421Z2016-09-22
00612649201238UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-8021ZD395-8021Z2016-09-22
00612649201283UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-6121ZD440-6121Z2016-09-22
00612649201306UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-80ZD440-80Z2016-09-22
00612649201337UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD445-80ZD445-80Z2016-09-22
00612649201597UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465-80ZD465-80Z2016-09-22
00612649201610UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465V-8021ZD465V-8021Z2016-09-22
00612649201627UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD466-6121ZD466-6121Z2016-09-22

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Primary DI, Brand, Company table
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