FDA.reportPublic FDA data

PowerFlow SyrinGun 20 mL

Primary DI
00199284270657
Brand
PowerFlow SyrinGun 20 mL
Company
ORTHOSPINE ADVANCE HEALTH, INC., A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION
Model
v1.0
Catalog number
PFSG-20
Device description
The PowerFlow SyrinGun is a high-performance 20 mL syringe-assist device designed to enhance syringe handling and optimize medication delivery in clinical settings.
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IQGAdaptor, Holder, Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284270657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284270657001992842706571992842706570199284270657

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-loaded medication/vaccine injector, manual, professionalA hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. This is a reusable device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058729384
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095074CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095173CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095180CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097290CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097306CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097313CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097559CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
00854073007103VIVI CAP SMARTTempramedIQG2025-12-09
00854073007127VIVI MEDTempramedIQG2025-12-09
00187207000467SealSafeAndwin ScientificIQG2025-08-14
00187207000474SealSafeAndwin ScientificIQG2025-08-14
00187207000481SealSafeAndwin ScientificIQG2025-08-14
00187207000498SealSafeAndwin ScientificIQG2025-08-14
00187207000504SealSafeAndwin ScientificIQG2025-08-14
00187207000511SealSafeAndwin ScientificIQG2025-08-14
00817771028849Celling Cardio Application KitCelling BiosciencesIQG2025-04-11
00817771029600Celling Application KitCelling BiosciencesIQG2025-04-11
00860425001620Certa Dose PALS Syringe Holder CD Acquisitions, LLCIQG2025-03-03
00614950030163ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031191ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031320ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00850003042305Extremity CareExtremity CareIQG2023-03-30
00854073007097VIVI EPITempramedIQG2022-09-01
00612479259966McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
00612479259973McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
08054083008172AbbVie Lightweight Vest XSABBVIE INC.IQG2021-10-19
08054083008189AbbVie Lightweight Vest SABBVIE INC.IQG2021-10-19
08054083008196AbbVie Lightweight Vest MABBVIE INC.IQG2021-10-19
08054083008202AbbVie Lightweight Vest LABBVIE INC.IQG2021-10-19