FDA.reportPublic FDA data

Delta Fly®

Primary DI
58032248368168
Brand
Delta Fly®
Company
DELTA MED SPA
Model
3681622
Device description
Delta Fly Micro Bore Winged Safety Needle
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140175000INTRAVASCULAR ADMINISTRATION SETDelta Med Spa2014-08-05FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38032248368164PackageGS160In Commercial Distribution
58032248368168PackageGS120In Commercial Distribution
08032248368163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803224836816438032248368164
5803224836816858032248368168
08032248368163080322483681638032248368163

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive device/collection of devices which includes a sharp and rigid needle intended to puncture a vein to collect blood and/or for transient (<24 hours) administration of intravenous (IV) fluids. The needle includes wings for fixation/placement and may include tubing/connectors; it is not, and does not include, a peripheral catheter. The device may be referred to as a butterfly needle or scalp vein needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Needle Gauge23Gauge
Outer Diameter0.6Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
444776777
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032248487123AtmosUD-462152025-09-02
08032248487147AtmosUD-A582452025-09-02
08032248487185Infusion SetMMT11732025-09-02
08032248490130AtmosUD-AELN2025-09-02
38032248487124AtmosUD-462152025-09-02
08032248487130AtmosUD-A362052025-09-02
38032248487148AtmosUD-A582452025-09-02
38032248487186Infusion SetMMT11732025-09-02
38032248490131AtmosUD-AELN2025-09-02
08032248471030Securmeter Foley ManometerHM0042025-05-19
38032248471031Securmeter Foley ManometerHM0042025-05-19
08032248127401NA12T74002016-09-23
08032248007123SOL CARE T SIV0012021-03-30
08032248007130SOL CARE T SIV0022021-03-30
08032248007147SOL CARE T SIV0032021-03-30
08032248007154SOL CARE T SIV0042021-03-30
08032248007161SOL CARE T SIV0052021-03-30
08032248007178SOL CARE T SIV0062021-03-30
08032248007185SOL CARE T SIV0072021-03-30
08032248007192SOL CARE T SIV0082021-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30