FDA.report

Comfort EZ

Primary DI
20850083784175
Company
S.D.I. USA, INC.
Model
HYP25G1S
Device description
Safety Hypodermic Needle 25G x 1" Ultra Thin Wall 100/bx 8bx/ ctn
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
116722847
Device count
100
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00850083784171PrimaryGS10
20850083784175Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00850083784171PrimaryGS10
20850083784175Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FMINeedle, Hypodermic, Single Lumen2General Hospital880.5570NIneligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes

TypeValueText
Length1 Inch
Needle Gauge25 Gauge

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20850083784007Comfort EZLL12026-02-13
20850083784045Comfort EZLL1INS2026-02-13
20850083784052Comfort EZHYP18G12026-02-13
20850083784274Comfort EZSS23G3ML12026-02-13
20850083784328Comfort EZSSTB25G1ML582026-02-13
20850083784342Comfort EZNS18G3ML1.52026-02-13
20850083784403Comfort EZBLN18G1.52026-02-13
10850002860709Comfort EZ ProSPN-30G850002-0860-702023-08-01
10850002860716Comfort EZ ProSPN-31G550002-0860-712023-08-01
10850002860723Comfort EZ ProSPN-31G450002-0860-722023-08-01
00850002860481Clever ChoiceUniversal Fit Reusable Nebulizer Kit2022-04-04
10850002860495Clever ChoiceUniversal Fit Reusable Nebulizer Kit - CHILD2022-04-04
00850002860375Clever Choice Comfort ProtectSDI-AUP50002-0860-372019-11-13
00850002860429Clever Choice Comfort ProtectSDI-AUP2550002-0860-422019-11-13
00850002860245Clever Choice Ultrasonic HumidifierCCH-40050002-0860-242019-11-08
10850002860228Clever ChoiceBPM - 85000286022150002-0860-222018-11-30
00850002860054Comfort EZ32G450002-0860-052019-01-24
00850002860023Comfort EZ31G850002-0860-022018-10-24
00850002860030Comfort EZ31G550002-0860-032018-10-26
00850002860047Comfort EZ31G650002-0860-042018-10-26

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